<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210000</url>
  </required_header>
  <id_info>
    <org_study_id>201159</org_study_id>
    <nct_id>NCT02210000</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of 12 Weeks of Once-daily Dosing of the Oral Motilin Receptor Agonist Camicinal, on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, double-blind, placebo controlled trial designed to confirm the&#xD;
      symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1&#xD;
      and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine&#xD;
      if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat administration improves&#xD;
      gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily&#xD;
      Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who&#xD;
      have documented abnormally slow gastric emptying and have symptoms consistent with&#xD;
      gastroparesis.&#xD;
&#xD;
      Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study&#xD;
      will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a&#xD;
      2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety&#xD;
      follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2014</start_date>
  <completion_date type="Actual">August 24, 2015</completion_date>
  <primary_completion_date type="Actual">August 24, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI-DD) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12</measure>
    <time_frame>Baseline (Screening) and Week 12</time_frame>
    <description>Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7, 8; fullness/early satiety subscale was mean of items 4, 6, 10, 11; bloating subscale was mean of items 5, 9. Total GCSI-DD score was mean of 3 subscales. For all, 0 indicated absence of symptom and higher score indicated greater severity of symptoms. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (&gt;160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of &lt; 110 and &gt; 220 milliseconds (msec), QRS interval of &lt;75 and &gt; 110 msec, absolute QTc interval of &gt; 450 to ≤ 480 or &gt; 480 to ≤ 500 or &gt;500 msec, and increase from Baseline in QTc of &gt; 30 to ≤ 60 msec or &gt;60 msec was considered as of abnormal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC &lt;1.5 Giga per Liter [G/L]), hemoglobin (&lt;25 or &gt;25 G/L), hematocrit (&lt;0.075 or &gt;0.075 %), platelet count (&lt;100 or &gt;500 G/L), lymphocytes low (&lt;0.8 G/L), and white blood cells (WBC &lt;3 G/L or &gt;20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration &gt;53 nano-grams per milliliter (ng/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (&lt;30 G/L), calcium low (&lt;2 or &gt;2.75 millimoles per Liter [mmol/L]), creatinine (&gt;44 micromoles per Liter change from baseline), Glucose (&lt;3 or &gt;18 mmol/L), potassium (&lt;3.0 or &gt;5.5 mmol/L), sodium (&lt;130 or &gt;150 mmol/L), and carbon di oxide (CO2) (&lt;18 or &gt;35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug</measure>
    <time_frame>Up to end of follow up (100 days)</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Plasma Concentration of Camicinal on Day 28 and Day 84</measure>
    <time_frame>Day 28 and Day 84</time_frame>
    <description>A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Camicinal 25mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camicinal</intervention_name>
    <description>Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning</description>
    <arm_group_label>Camicinal 25mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 or 2 diabetes mellitus (acetylated hemoglobin A1 [HbA1c] &lt;=11.0%)&#xD;
&#xD;
          -  Male or female between 18 and 80 years of age, inclusive.&#xD;
&#xD;
          -  Patient has gastroparesis at screening. A patient is eligible if one of the following&#xD;
             criteria are met: Gastric half-time of emptying &gt;upper limit of normal as determined&#xD;
             by Carbon-13 radioisotope (C13) oral breath test; % C13-dose recovered &lt; lower limit&#xD;
             of normal at 90 or 120 minutes&#xD;
&#xD;
          -  Patient must report a &gt;=3 month history of relevant symptoms of gastroparesis (e.g.,&#xD;
             chronic post-prandial fullness, early satiety, post-prandial nausea).&#xD;
&#xD;
          -  Patients will have a mean of the daily scores over a minimum of 7 days indicating &gt;=&#xD;
             mild (2) severity for the fullness/early satiety subscale as assessed using the&#xD;
             GCSI-DD during the screening period prior to randomization.&#xD;
&#xD;
          -  A female patient is eligible to participate if she is of non-childbearing potential&#xD;
             defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or&#xD;
             postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a&#xD;
             blood sample with simultaneous follicle stimulating hormone [FSH] &gt;40 milli&#xD;
             international units per milliliter [mIU/mL], or a value consistent with the local&#xD;
             laboratory standard value, is confirmatory) or is of child-bearing potential and&#xD;
             agrees to use contraception methods for an appropriate period of time (as determined&#xD;
             by the product label or investigator) prior to the start of dosing to sufficiently&#xD;
             minimize the risk of pregnancy at that point. Female patients must agree to use&#xD;
             contraception for at least 5 days following the last dose of study medication.&#xD;
&#xD;
          -  Body mass index (BMI) &gt;18 and &lt;=42.0 kilogram per meter square (kg/m^2) (inclusive).&#xD;
&#xD;
          -  QTc &lt;450 millisecond (msec) or QTc &lt;480 msec in patients with Bundle Branch Block&#xD;
             based on single or average QTc value of triplicate values obtained over a brief&#xD;
             recording period. The QT correction formula (Bazett's, Fridericia's, etc) used to&#xD;
             determine inclusion and discontinuation should be the same throughout the study.&#xD;
&#xD;
          -  Aspartate aminotransferase and alanine aminotransferase &lt;2x upper limit of normal&#xD;
             (ULN); alkaline phosphatase and bilirubin &lt;=1.5xULN (isolated bilirubin &gt;1.5xULN is&#xD;
             acceptable if bilirubin is fractionated and direct bilirubin &lt;35%).&#xD;
&#xD;
          -  Capable of giving written informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has acute severe gastroenteritis&#xD;
&#xD;
          -  Patient has a gastric pacemaker&#xD;
&#xD;
          -  Patient is on chronic enteral (e.g., feeding tube) or parenteral feeding&#xD;
&#xD;
          -  Recent (last 6 weeks) history of poor control of diabetes e.g. hypoglycaemia requiring&#xD;
             medical intervention, diabetic ketoacidosis, admission for control of diabetes or&#xD;
             complications of diabetes&#xD;
&#xD;
          -  Patient has evidence of severe cardiovascular autonomic neuropathy (e.g. history of&#xD;
             recurrent syncope in the last 6 months)&#xD;
&#xD;
          -  Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia)&#xD;
&#xD;
          -  Use of medications potentially influencing upper gastrointestinal motility or appetite&#xD;
             at least 1 week prior to screening (e.g., prokinetic drugs, macrolide antibiotics&#xD;
             [erythromycin], glucagon-like peptide-1 [GLP-1] mimetics)&#xD;
&#xD;
          -  Patient has had intrapyloric botox injections.&#xD;
&#xD;
          -  A patient would be eligible if the botox treatment was in the past (&gt;6 months&#xD;
             previously) and was not being repeated.&#xD;
&#xD;
          -  Patient has had a gastrectomy, or major gastric surgical procedure or any evidence of&#xD;
             bowel obstruction or strictures within the previous 12 months&#xD;
&#xD;
          -  Dosage of any concomitant medications has not been stable for at least 3 weeks, except&#xD;
             for routine adjustments in daily insulin treatments.&#xD;
&#xD;
          -  Estimated (or measured) glomerular filtration rate &lt;=30 mL/minute.&#xD;
&#xD;
          -  Daily opiate use at screening&#xD;
&#xD;
          -  Use of prohibited medications that potentially influence upper gastrointestinal&#xD;
             motility or appetite, or medications that may interfere with the methods of measuring&#xD;
             gastric emptying e.g., prokinetic drugs, macrolide antibiotics (erythromycin,&#xD;
             azithromycin), GLP-1 mimetics, anti-cholinergics, chronic/regular use of opiates&#xD;
&#xD;
          -  History or presence of clinically significant gastro-intestinal, hepatic or renal&#xD;
             disease (including liver disease or known hepatic or biliary abnormalities, with the&#xD;
             exception of Gilbert's syndrome or asymptomatic gallstones) or other condition that&#xD;
             would in the opinion of the investigator or medical monitor make the subject&#xD;
             unsuitable for inclusion in this clinical study.&#xD;
&#xD;
          -  Concurrent enrollment in any other interventional study/(ies) involving a novel (i.e.&#xD;
             unapproved or experimental) chemical or biopharmaceutical entity.&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof or a&#xD;
             history of drug or other allergy that, in the opinion of the investigator or&#xD;
             GlaxoSmithKline Medical Monitor, contraindicates their participation.&#xD;
&#xD;
          -  Lactating or Pregnant females as determined by positive serum or urine human chorionic&#xD;
             gonadotropin test (from the first urine of the day) at screening or prior to dosing.&#xD;
&#xD;
          -  A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody&#xD;
             result within 3 months of screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Inverness</city>
        <state>Florida</state>
        <zip>34452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>49519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spring</city>
        <state>Texas</state>
        <zip>77379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bountiful</city>
        <state>Utah</state>
        <zip>84010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>August 22, 2017</results_first_submitted>
  <results_first_submitted_qc>September 29, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 1, 2017</results_first_posted>
  <disposition_first_submitted>February 22, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>February 22, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 22, 2016</disposition_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>repeat dose</keyword>
  <keyword>phase II</keyword>
  <keyword>GCSI-DD</keyword>
  <keyword>pharmacodynamics</keyword>
  <keyword>gastroparesis</keyword>
  <keyword>type 1 and type 2 diabetes mellitus</keyword>
  <keyword>camicinal</keyword>
  <keyword>GSK962040</keyword>
  <keyword>symptoms</keyword>
  <keyword>gut motility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted from 27 August 2014 till 24 August 2015 across 34 centers in the united states (US). A total of 120 participants with gastroparesis and Type 1 or 2 diabetes mellitus were planned to be enrolled.</recruitment_details>
      <pre_assignment_details>A total of 387 participants with gastroparesis and Type 1 or 2 diabetes mellitus were screened, of which 273 participants did not meet the inclusion/exclusion criteria and thus, were screen failures. A total of 114 participants were randomized in the study. Participants started recording GCSI-DD for 7 days post-screening to assess baseline symptoms</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CAMICINAL 25 MG</title>
          <description>Eligible participants received oral Camicinal 25 milligrams (mg) once daily in the morning with 100 milliliter (mL) of water up to 84 days and were followed-up for 2 weeks.</description>
        </group>
        <group group_id="P2">
          <title>PLACEBO</title>
          <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included participants who received at least one dose of the study drug and were followed-up for at least one post-baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of camicinal in blood and therefore was analyzed in the camicinal group.</population>
      <group_list>
        <group group_id="B1">
          <title>CAMICINAL 25 MG</title>
          <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
        </group>
        <group group_id="B2">
          <title>PLACEBO</title>
          <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="58"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="114"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.3" spread="12.47"/>
                    <measurement group_id="B2" value="58.3" spread="9.81"/>
                    <measurement group_id="B3" value="57.8" spread="11.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI-DD) at Week 12</title>
        <description>The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.</description>
        <time_frame>Week 12</time_frame>
        <population>Intent-to-treat (ITT) Population comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI-DD) at Week 12</title>
          <description>The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.</description>
          <population>Intent-to-treat (ITT) Population comprised of all randomized participants.</population>
          <units>Percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.32"/>
                    <measurement group_id="O2" value="42.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <p_value_desc>Posterior probability of the treatment difference in response rate at Week 12 being greater than 0%.</p_value_desc>
            <method>Bayesian method</method>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.212</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3716</ci_lower_limit>
            <ci_upper_limit>-0.0448</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12</title>
        <description>Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7, 8; fullness/early satiety subscale was mean of items 4, 6, 10, 11; bloating subscale was mean of items 5, 9. Total GCSI-DD score was mean of 3 subscales. For all, 0 indicated absence of symptom and higher score indicated greater severity of symptoms. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.</description>
        <time_frame>Baseline (Screening) and Week 12</time_frame>
        <population>ITT Population. Only those participants available at the time of assessment were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12</title>
          <description>Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7, 8; fullness/early satiety subscale was mean of items 4, 6, 10, 11; bloating subscale was mean of items 5, 9. Total GCSI-DD score was mean of 3 subscales. For all, 0 indicated absence of symptom and higher score indicated greater severity of symptoms. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.</description>
          <population>ITT Population. Only those participants available at the time of assessment were included in the analysis.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.250" spread="0.1714"/>
                    <measurement group_id="O2" value="-1.460" spread="0.1765"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feeling full after meals</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.063" spread="0.2102"/>
                    <measurement group_id="O2" value="-1.812" spread="0.2146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.382" spread="0.2227"/>
                    <measurement group_id="O2" value="-1.871" spread="0.2270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to finish normal meal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.876" spread="0.1819"/>
                    <measurement group_id="O2" value="-1.373" spread="0.1858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retching</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.894" spread="0.1517"/>
                    <measurement group_id="O2" value="-0.944" spread="0.1554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.532" spread="0.1112"/>
                    <measurement group_id="O2" value="-0.494" spread="0.1144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stomach visiblly larger</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.998" spread="0.2124"/>
                    <measurement group_id="O2" value="-1.473" spread="0.2165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stomach fullness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.200" spread="0.2090"/>
                    <measurement group_id="O2" value="-1.661" spread="0.2124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of appetite</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.930" spread="0.1732"/>
                    <measurement group_id="O2" value="-1.465" spread="0.1774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper abdominal pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.186" spread="0.1887"/>
                    <measurement group_id="O2" value="-1.383" spread="0.1922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper abdominal discomfort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.304" spread="0.2051"/>
                    <measurement group_id="O2" value="-1.618" spread="0.2097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall severity of GP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.173" spread="0.1626"/>
                    <measurement group_id="O2" value="-1.557" spread="0.1667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea/vomiting subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.888" spread="0.1183"/>
                    <measurement group_id="O2" value="-0.956" spread="0.1216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fullness/Early Satiety Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.041" spread="0.1696"/>
                    <measurement group_id="O2" value="-1.589" spread="0.1725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.189" spread="0.2115"/>
                    <measurement group_id="O2" value="-1.668" spread="0.2153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total GCSI-DD scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.037" spread="0.1470"/>
                    <measurement group_id="O2" value="-1.393" spread="0.1498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Nausea at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.210</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2353</ci_lower_limit>
            <ci_upper_limit>0.6553</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Feeling full after meals at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.749</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2275</ci_lower_limit>
            <ci_upper_limit>1.2705</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Bloating at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.489</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0592</ci_lower_limit>
            <ci_upper_limit>1.0374</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Not able to finish meal at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.497</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0396</ci_lower_limit>
            <ci_upper_limit>0.9550</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Retching at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.050</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3386</ci_lower_limit>
            <ci_upper_limit>0.4395</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vomiting at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.038</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3242</ci_lower_limit>
            <ci_upper_limit>0.2492</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stomach visibly larger at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.475</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0483</ci_lower_limit>
            <ci_upper_limit>0.9978</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stomach fullness at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.461</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0519</ci_lower_limit>
            <ci_upper_limit>0.9748</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Loss of appetite at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.536</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0967</ci_lower_limit>
            <ci_upper_limit>0.9745</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Upper abdominal pain at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.196</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2746</ci_lower_limit>
            <ci_upper_limit>0.6671</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Upper abdominal discomfort at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.314</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2013</ci_lower_limit>
            <ci_upper_limit>0.8292</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall severity of your GP symptoms at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.384</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0323</ci_lower_limit>
            <ci_upper_limit>0.7997</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Nausea/Vomiting Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.068</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2366</ci_lower_limit>
            <ci_upper_limit>0.3723</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fullness/Early Satiety Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.548</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1333</ci_lower_limit>
            <ci_upper_limit>0.9628</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Bloating Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.479</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0386</ci_lower_limit>
            <ci_upper_limit>0.9966</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Total GCSI-DD at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.356</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0049</ci_lower_limit>
            <ci_upper_limit>0.7179</ci_upper_limit>
            <estimate_desc>A negative difference indicated greater improvement in the Camicinal group compared to Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days</title>
        <description>Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (&gt;160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.</description>
        <time_frame>Up to 100 days</time_frame>
        <population>Safety Population comprised of participants who received at least one dose of the study drug and were followed-up for at least one post-Baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days</title>
          <description>Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (&gt;160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.</description>
          <population>Safety Population comprised of participants who received at least one dose of the study drug and were followed-up for at least one post-Baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP, ABS: &gt; 160</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, CFB: INCREASE &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, CFB: INCREASE &gt;=40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, CFB: DECREASE &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, CFB: DECREASE &gt;=40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, ABS: &gt;100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, CFB: INCREASE &gt;=10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, CFB: INCREASE &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, CFB: DECREASE &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, CFB: DECREASE &gt;=10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day</title>
        <description>Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.</description>
        <time_frame>Up to 100 days</time_frame>
        <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day</title>
          <description>Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.</description>
          <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABS: &gt;110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB: INCREASE &gt;=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB: INCREASE &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB: DECREASE &gt;=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB: DECREASE &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days</title>
        <description>The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of &lt; 110 and &gt; 220 milliseconds (msec), QRS interval of &lt;75 and &gt; 110 msec, absolute QTc interval of &gt; 450 to ≤ 480 or &gt; 480 to ≤ 500 or &gt;500 msec, and increase from Baseline in QTc of &gt; 30 to ≤ 60 msec or &gt;60 msec was considered as of abnormal.</description>
        <time_frame>Up to 100 days</time_frame>
        <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days</title>
          <description>The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of &lt; 110 and &gt; 220 milliseconds (msec), QRS interval of &lt;75 and &gt; 110 msec, absolute QTc interval of &gt; 450 to ≤ 480 or &gt; 480 to ≤ 500 or &gt;500 msec, and increase from Baseline in QTc of &gt; 30 to ≤ 60 msec or &gt;60 msec was considered as of abnormal.</description>
          <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BASELINE, NORMAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASELINE, ABNORMAL - NOT CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASELINE, ABNORMAL - CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 14, NORMAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 14, ABNORMAL - NOT CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 14, ABNORMAL - CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 28, NORMAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 28, ABNORMAL - NOT CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 28, ABNORMAL - CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 56, NORMAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 56, ABNORMAL - NOT CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 56, ABNORMAL - CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 84, NORMAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 84, ABNORMAL - NOT CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 84, ABNORMAL - CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOLLOW-UP, NORMAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOLLOW-UP, ABNORMAL - NOT CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FOLLOW-UP, ABNORMAL - CLINICALLY SIGNIFICANT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period</title>
        <description>Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC &lt;1.5 Giga per Liter [G/L]), hemoglobin (&lt;25 or &gt;25 G/L), hematocrit (&lt;0.075 or &gt;0.075 %), platelet count (&lt;100 or &gt;500 G/L), lymphocytes low (&lt;0.8 G/L), and white blood cells (WBC &lt;3 G/L or &gt;20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration &gt;53 nano-grams per milliliter (ng/mL).</description>
        <time_frame>Up to 100 days</time_frame>
        <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period</title>
          <description>Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC &lt;1.5 Giga per Liter [G/L]), hemoglobin (&lt;25 or &gt;25 G/L), hematocrit (&lt;0.075 or &gt;0.075 %), platelet count (&lt;100 or &gt;500 G/L), lymphocytes low (&lt;0.8 G/L), and white blood cells (WBC &lt;3 G/L or &gt;20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration &gt;53 nano-grams per milliliter (ng/mL).</description>
          <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>tANC, L, &lt;1.5, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>tANC, L, &lt;1.5, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, H, CFB &gt;25, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, H, CFB &gt;25, Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, L, CFB &lt; -25, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, H, CFB &gt;25, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, H, &gt;0.54, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, H, &gt;0.54, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, H, &gt;0.54, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, H, CFB &gt;0.075, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, H, CFB &gt;0.075, Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, L, CFB, &gt;0.54, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, L, CFB, &lt; -0.075, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, H, CFB, &gt;0.075, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count, L, &lt;100, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count, L, &lt;100, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count, L, &lt;100, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, L, &lt;0.8, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period</title>
        <description>Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (&lt;30 G/L), calcium low (&lt;2 or &gt;2.75 millimoles per Liter [mmol/L]), creatinine (&gt;44 micromoles per Liter change from baseline), Glucose (&lt;3 or &gt;18 mmol/L), potassium (&lt;3.0 or &gt;5.5 mmol/L), sodium (&lt;130 or &gt;150 mmol/L), and carbon di oxide (CO2) (&lt;18 or &gt;35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.</description>
        <time_frame>Up to 100 days</time_frame>
        <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period</title>
          <description>Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (&lt;30 G/L), calcium low (&lt;2 or &gt;2.75 millimoles per Liter [mmol/L]), creatinine (&gt;44 micromoles per Liter change from baseline), Glucose (&lt;3 or &gt;18 mmol/L), potassium (&lt;3.0 or &gt;5.5 mmol/L), sodium (&lt;130 or &gt;150 mmol/L), and carbon di oxide (CO2) (&lt;18 or &gt;35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.</description>
          <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Creatinine, H, CFB&gt;44, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, H, CFB&gt;44, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, H, CFB&gt;44, Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, H, &gt;18, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, H, &gt;18, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, L, &lt;3.0, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, H, &gt;18, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, H, &gt;18, Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, H, &gt;18, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, H, &gt;5.5, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, H, &gt;5.5, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, H, &gt;5.5, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, H, &gt;5.5, Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, H, &gt;5.5, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, L, &lt;130, Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, L, &lt;130, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carbon di oxide, L, &lt;18, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carbon di oxide, L, &lt;18, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carbon di oxide, L, &lt;18, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carbon di oxide, L, &lt;18, Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carbon di oxide, L, &lt;18, Day 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.</description>
        <time_frame>Up to end of follow up (100 days)</time_frame>
        <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.</description>
          <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>WITH ANY AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WITH ANY SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WITH AE LEADING TO DISCONTINUATION</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trough Plasma Concentration of Camicinal on Day 28 and Day 84</title>
        <description>A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.</description>
        <time_frame>Day 28 and Day 84</time_frame>
        <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
        <group_list>
          <group group_id="O1">
            <title>CAMICINAL 25 MG</title>
            <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Plasma Concentration of Camicinal on Day 28 and Day 84</title>
          <description>A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.</description>
          <population>Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.</population>
          <units>NANOGRAM PER MILLILITER (NG/ML)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DAY 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.746" spread="121.7083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.382" spread="132.5696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to end of follow up (100 days).</time_frame>
      <desc>Safety Population comprised of participants who received at least one dose of the study drug and were followed-up for at least one post-Baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of camicinal in blood and therefore was analyzed in the camicinal group.</desc>
      <group_list>
        <group group_id="E1">
          <title>CAMICINAL 25 MG</title>
          <description>Eligible participants received oral Camicinal 25 mg once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
        </group>
        <group group_id="E2">
          <title>PLACEBO</title>
          <description>Eligible participants received oral matching Placebo once daily in the morning with 100 mL of water up to 84 days and were followed-up for 2 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>DEPRESSION SUICIDAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>TOOTH INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOGLYCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>SYNOVIAL CYST</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210000
org study id: 201159
nct id: NCT02210000
lead sponsor: 
has dmc: No
This study is a randomized, double-blind, placebo controlled trial designed to confirm the
      symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1
      and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine
      if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat administration improves
      gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily
      Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who
      have documented abnormally slow gastric emptying and have symptoms consistent with
      gastroparesis.

      Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study
      will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a
      2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety
      follow-up visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI-DD) at Week 12
time frame: Week 12
description: The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.
measure: Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12
time frame: Baseline (Screening) and Week 12
description: Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7, 8; fullness/early satiety subscale was mean of items 4, 6, 10, 11; bloating subscale was mean of items 5, 9. Total GCSI-DD score was mean of 3 subscales. For all, 0 indicated absence of symptom and higher score indicated greater severity of symptoms. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.
measure: Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days
time frame: Up to 100 days
description: Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (>160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.
measure: Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day
time frame: Up to 100 days
description: Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.
measure: Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days
time frame: Up to 100 days
description: The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of < 110 and > 220 milliseconds (msec), QRS interval of <75 and > 110 msec, absolute QTc interval of > 450 to ≤ 480 or > 480 to ≤ 500 or >500 msec, and increase from Baseline in QTc of > 30 to ≤ 60 msec or >60 msec was considered as of abnormal.
measure: Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period
time frame: Up to 100 days
description: Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC <1.5 Giga per Liter [G/L]), hemoglobin (<25 or >25 G/L), hematocrit (<0.075 or >0.075 %), platelet count (<100 or >500 G/L), lymphocytes low (<0.8 G/L), and white blood cells (WBC <3 G/L or >20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration >53 nano-grams per milliliter (ng/mL).
measure: Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period
time frame: Up to 100 days
description: Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (<30 G/L), calcium low (<2 or >2.75 millimoles per Liter [mmol/L]), creatinine (>44 micromoles per Liter change from baseline), Glucose (<3 or >18 mmol/L), potassium (<3.0 or >5.5 mmol/L), sodium (<130 or >150 mmol/L), and carbon di oxide (CO2) (<18 or >35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug
time frame: Up to end of follow up (100 days)
description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.
measure: Trough Plasma Concentration of Camicinal on Day 28 and Day 84
time frame: Day 28 and Day 84
description: A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84
arm group label: Camicinal 25mg
arm group type: Experimental
description: Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84
intervention type: Drug
intervention name: Placebo
description: Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning
arm group label: Placebo
intervention type: Drug
intervention name: Camicinal
description: Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning
arm group label: Camicinal 25mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: United States
responsible party type: Sponsor
mesh term: Gastroparesis
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