<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/NCT03012594</url>
  </required_header>
  <id_info>
    <org_study_id>HS16-0465</org_study_id>
    <nct_id>NCT03012594</nct_id>
  </id_info>
  <brief_title>Lanreotide in the Treatment of Small Bowel Motility Disorders</brief_title>
  <official_title>A Pilot Study to Evaluate Safety and Effectiveness of Lanreotide in the Treatment of Patients With Small Bowel Motility Disorders (SBMD): a Prospective, Non-randomized, Single-center Study of 20 Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a human research study looking at the effectiveness of Lanreotide (study medication)&#xD;
      in treating small bowel motility disorders. It is similar to a natural hormone somatostatin&#xD;
      that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a&#xD;
      growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting&#xD;
      medication that is given once a month. It is marketed with a trade name &quot;Somatuline Depot&quot;.&#xD;
      It is given deep subcutaneously (deep within the layers of the skin) in the superior external&#xD;
      quadrant of the buttock. Injection site will be alternated on subsequent injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that in patients with small bowel motility disorders,&#xD;
      Lanreotide helps in alleviating the symptoms. Lanreotide is an FDA approved medication for&#xD;
      management of acromegaly and neuroendocrine tumors, but has never been used for treating&#xD;
      small bowel motility disorders. However, Octreotide which is similar to Lanreotide but is a&#xD;
      short acting synthetic somatostatin has been used in few research studies.&#xD;
&#xD;
      If a patient is interested and qualifies for the study then he/she will be explained about&#xD;
      the study and signature will be collected on the consent form. Health and social history will&#xD;
      be collected. Blood work, urine analysis, pregnancy test (in women of reproductive age group&#xD;
      and have the capability of getting pregnant)) will be performed to make sure that patient&#xD;
      qualifies for the study and for follow-up during the treatment. Physical examination, ECG,&#xD;
      wireless motility capsule testing and hydrogen breath testing will be performed. Patients&#xD;
      will be required to complete a questionnaire regarding their health.&#xD;
&#xD;
      The total study duration from the first administration of study drug is 12 weeks. The study&#xD;
      medication will be given once a month for 3 months and there is a 1 month follow-up after the&#xD;
      last study medication. There will be a screening visit approximately 1 month before the first&#xD;
      study drug administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2017</start_date>
  <completion_date type="Actual">March 11, 2019</completion_date>
  <primary_completion_date type="Actual">October 21, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill</measure>
    <time_frame>3 months</time_frame>
    <description>If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to &lt; 6hrs, then patient would be considered a responder and that lanreotide is efficacious.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Symptoms as Accessed by &quot;Patient Assessment of Upper GastroIntestinal Symptom Severity Index&quot;</measure>
    <time_frame>3 months</time_frame>
    <description>Improvement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms.&#xD;
The participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
PAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Gastrointestinal Motility Disorder</condition>
  <condition>Intestinal Disease</condition>
  <arm_group>
    <arm_group_label>Lanreotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanreotide</intervention_name>
    <description>Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart</description>
    <arm_group_label>Lanreotide</arm_group_label>
    <other_name>Somatuline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Consecutive patients with evidence of small bowel motility disorders, referred to (or)&#xD;
             are patients of the Gastroenterology and Motility Center at Northwell Health System.&#xD;
&#xD;
          2. Aged between 18 and 70 years.&#xD;
&#xD;
          3. Subjects should be capable of understanding the study and be able to give informed&#xD;
             consent.&#xD;
&#xD;
          4. Patient having small bowel motility disorder as evidenced by delayed small bowel&#xD;
             transit by wireless motility capsule (WMC) testing to &gt; 6 hours.&#xD;
&#xD;
          5. To participate in the study, patients will have to stop taking Octreotide (because it&#xD;
             has the same mechanism of action as the study medication) if they are currently taking&#xD;
             it; it should be stopped for at least 4 weeks before taking the first dose of this&#xD;
             study medication.&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          1. Age &lt;18 or age &gt;70&#xD;
&#xD;
          2. Pregnancy as assessed by urine pregnancy test.&#xD;
&#xD;
        Exclusion Criteria for performing wireless motility capsule testing&#xD;
&#xD;
          1. History of gastric bezoar&#xD;
&#xD;
          2. History of Disorders of swallowing&#xD;
&#xD;
          3. Known or suspected small bowel diverticula, diverticulitis, strictures, fistulas,&#xD;
             Crohn's disease, or any other relevant medical comorbidity (e.g. chronic alcohol&#xD;
             abuse)&#xD;
&#xD;
          4. Prior intestinal surgery, including Ileocecal(IC) valve resection or gastrointestinal&#xD;
             surgeries that create a blind loop (e.g. Bilroth II or Roux-en-Y)&#xD;
&#xD;
          5. History of Severe dysphagia to food or pills&#xD;
&#xD;
          6. A participant who uses an implanted or portable electro-mechanical medical device such&#xD;
             as a cardiac pacemaker or infusion pump&#xD;
&#xD;
          7. Inability to be off intestinal transit altering medication for at least one week (e.g.&#xD;
             opiates, laxatives, etc.)&#xD;
&#xD;
          8. Any person unable or unwilling to undergo abdominal surgery.&#xD;
&#xD;
          9. BMI &gt; 40.&#xD;
&#xD;
        Exclusion Criteria due to Lanreotide&#xD;
&#xD;
          1. Current use or recent (within last 7 days) use of acid suppressive therapy, prokinetic&#xD;
             agents, laxatives, and opiates, or other agents known to affect gastrointestinal&#xD;
             motility.&#xD;
&#xD;
          2. Disorders associated with presumed small intestinal motility disorders including:&#xD;
             scleroderma, intestinal pseudo-obstruction, and autonomic visceral neuropathy (e.g.&#xD;
             longstanding diabetes of more than 20 years and/or poorly controlled diabetes (glucose&#xD;
             &gt; 250, glycosylated hemoglobin (HbA1c) &gt; 8.5%)&#xD;
&#xD;
          3. Current use of cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called&#xD;
             bromocriptine (Parlodel, Cycloset), or medicines that lower heart rate, such as beta&#xD;
             blockers.&#xD;
&#xD;
          4. Cardiac arrhythmia based on health history (palpitations, feeling a pause between&#xD;
             heartbeats, lightheadedness, passing out, shortness of breath, or chest pain).&#xD;
&#xD;
             Bradycardia and Tachycardia are monitored during every visit to the clinic, using&#xD;
             pulse rate.&#xD;
&#xD;
             ECG will be performed during screening visit and during 8th week of the study. The&#xD;
             following are accessed with ECG.&#xD;
&#xD;
               -  Bradycardia &lt;60 beats/min.&#xD;
&#xD;
               -  Tachycardia &gt;100 beats/min.&#xD;
&#xD;
               -  Atrial Fibrillation - Rapid irregular atrial signal with no real P-waves and&#xD;
                  irregular ventricular rate.&#xD;
&#xD;
               -  Ventricular Fibrillation - Irregular ventricular waveforms.&#xD;
&#xD;
               -  Sinus Arrhythmia - Normal beats, but triggered at an irregular interval from 60&#xD;
                  to 100 beats per minute, causing varying R-R interval.&#xD;
&#xD;
               -  Missed beats.&#xD;
&#xD;
          5. Chronic kidney disease (moderate and severe renal impairment as calculated by&#xD;
             creatinine clearance of &lt;50 mL/min)&#xD;
&#xD;
          6. Hepatic Impairment - Subjects with Child-Pugh Class B and Class C.&#xD;
&#xD;
          7. Significant electrolyte abnormalities: Anything outside of the normal range by +/- 20&#xD;
             % will be considered as abnormal.&#xD;
&#xD;
          8. Cholelithiasis (Total bilirubin &gt;2x of normal)&#xD;
&#xD;
          9. Pancreatitis&#xD;
&#xD;
         10. Hepatitis (Aspartate transaminase (AST), Alanine transaminase (ALT) or Alkaline&#xD;
             phosphatase (Alk Ph), greater than upper limit of normal(ULN), Serum albumin &lt;3.0 g/dL&#xD;
             unless prothrombin time is within the normal range)&#xD;
&#xD;
         11. Present cholecystitis&#xD;
&#xD;
         12. Uncontrolled congestive heart failure&#xD;
&#xD;
         13. Known hypersensitivity to the study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larry Miller, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Soudah HC, Hasler WL, Owyang C. Effect of octreotide on intestinal motility and bacterial overgrowth in scleroderma. N Engl J Med. 1991 Nov 21;325(21):1461-7. doi: 10.1056/NEJM199111213252102.</citation>
    <PMID>1944424</PMID>
  </reference>
  <reference>
    <citation>Owyang C. Octreotide in gastrointestinal motility disorders. Gut. 1994;35(3 Suppl):S11-4. doi: 10.1136/gut.35.3_suppl.s11.</citation>
    <PMID>8206395</PMID>
  </reference>
  <reference>
    <citation>Edmunds MC, Chen JD, Soykan I, Lin Z, McCallum RW. Effect of octreotide on gastric and small bowel motility in patients with gastroparesis. Aliment Pharmacol Ther. 1998 Feb;12(2):167-74. doi: 10.1046/j.1365-2036.1998.00289.x.</citation>
    <PMID>9692691</PMID>
  </reference>
  <reference>
    <citation>Faure C, Goulet O, Ategbo S, Breton A, Tounian P, Ginies JL, Roquelaure B, Despres C, Scaillon M, Maurage C, Paquot I, Hermier M, De Napoli S, Dabadie A, Huet F, Baudon JJ, Larchet M. Chronic intestinal pseudoobstruction syndrome: clinical analysis, outcome, and prognosis in 105 children. French-Speaking Group of Pediatric Gastroenterology. Dig Dis Sci. 1999 May;44(5):953-9. doi: 10.1023/a:1026656513463.</citation>
    <PMID>10235603</PMID>
  </reference>
  <reference>
    <citation>Stanghellini V, Cogliandro RF, de Giorgio R, Barbara G, Salvioli B, Corinaldesi R. Chronic intestinal pseudo-obstruction: manifestations, natural history and management. Neurogastroenterol Motil. 2007 Jun;19(6):440-52. doi: 10.1111/j.1365-2982.2007.00902.x.</citation>
    <PMID>17564625</PMID>
  </reference>
  <reference>
    <citation>Mann SD, Debinski HS, Kamm MA. Clinical characteristics of chronic idiopathic intestinal pseudo-obstruction in adults. Gut. 1997 Nov;41(5):675-81. doi: 10.1136/gut.41.5.675.</citation>
    <PMID>9414977</PMID>
  </reference>
  <reference>
    <citation>Lybaert W. The use of lanreotide autogel(R) in the treatment of intestinal obstruction in a patient with adenocarcinoma. Case Rep Oncol. 2014 Jan 16;7(1):43-6. doi: 10.1159/000358124. eCollection 2014 Jan.</citation>
    <PMID>24575015</PMID>
  </reference>
  <reference>
    <citation>Lamrani A, Vidon N, Sogni P, Nepveux P, Catus F, Blumberg J, Chaussade S. Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans. Br J Clin Pharmacol. 1997 Jan;43(1):65-70. doi: 10.1111/j.1365-2125.1997.tb00034.x.</citation>
    <PMID>9056054</PMID>
  </reference>
  <reference>
    <citation>Camilleri M. Small bowel motility disorders. Rev Gastroenterol Mex. 1994 Apr-Jun;59(2):120-6.</citation>
    <PMID>7991964</PMID>
  </reference>
  <reference>
    <citation>Wang C, Xu H, Chen H, Li J, Zhang B, Tang C, Ghishan FK. Somatostatin stimulates intestinal NHE8 expression via p38 MAPK pathway. Am J Physiol Cell Physiol. 2011 Feb;300(2):C375-82. doi: 10.1152/ajpcell.00421.2010. Epub 2010 Nov 24.</citation>
    <PMID>21106692</PMID>
  </reference>
  <reference>
    <citation>Giustina A, Chanson P, Bronstein MD, Klibanski A, Lamberts S, Casanueva FF, Trainer P, Ghigo E, Ho K, Melmed S; Acromegaly Consensus Group. A consensus on criteria for cure of acromegaly. J Clin Endocrinol Metab. 2010 Jul;95(7):3141-8. doi: 10.1210/jc.2009-2670. Epub 2010 Apr 21.</citation>
    <PMID>20410227</PMID>
  </reference>
  <reference>
    <citation>Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.</citation>
    <PMID>20195905</PMID>
  </reference>
  <reference>
    <citation>Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.</citation>
    <PMID>15354277</PMID>
  </reference>
  <reference>
    <citation>Rentz AM, Kahrilas P, Stanghellini V, Tack J, Talley NJ, de la Loge C, Trudeau E, Dubois D, Revicki DA. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res. 2004 Dec;13(10):1737-49. doi: 10.1007/s11136-004-9567-x.</citation>
    <PMID>15651544</PMID>
  </reference>
  <reference>
    <citation>De Giorgio R, Sarnelli G, Corinaldesi R, Stanghellini V. Advances in our understanding of the pathology of chronic intestinal pseudo-obstruction. Gut. 2004 Nov;53(11):1549-52. doi: 10.1136/gut.2004.043968.</citation>
    <PMID>15479666</PMID>
  </reference>
  <reference>
    <citation>Iida H, Ohkubo H, Inamori M, Nakajima A, Sato H. Epidemiology and clinical experience of chronic intestinal pseudo-obstruction in Japan: a nationwide epidemiologic survey. J Epidemiol. 2013;23(4):288-94. doi: 10.2188/jea.je20120173.</citation>
    <PMID>23831693</PMID>
  </reference>
  <reference>
    <citation>Goulet O, Sauvat F, Jan D. Surgery for pediatric patients with chronic intestinal pseudo-obstruction syndrome. J Pediatr Gastroenterol Nutr. 2005 Sep;41 Suppl 1:S66-8. doi: 10.1097/01.scs.0000180312.55417.8e. No abstract available.</citation>
    <PMID>16131977</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <results_first_submitted>November 23, 2020</results_first_submitted>
  <results_first_submitted_qc>December 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 15, 2021</results_first_posted>
  <last_update_submitted>December 23, 2020</last_update_submitted>
  <last_update_submitted_qc>December 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Larry Miller</investigator_full_name>
    <investigator_title>Chief of Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>Small bowel motility disorder</keyword>
  <keyword>Slow intestinal motility</keyword>
  <keyword>Small bowel bacterial overgrowth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lanreotide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03012594/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First subject was enrolled on 5/11/2017 and the last subject was enrolled on 7/19/2018. All study visits were performed either at a medical clinic or gastroenterology unit. There were also phone follow-ups.</recruitment_details>
      <pre_assignment_details>This is an open label non-randomized study. All enrolled participants were checked to see if they meet all the screening requirements to participate. All willing and qualified participants received the study mediation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lanreotide</title>
          <description>Open label&#xD;
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lanreotide</title>
          <description>Open label&#xD;
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </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="46.78" spread="13.33"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.11" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart rate</title>
          <units>beats/sec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.67" spread="10.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic blood pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Glucose</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118" spread="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Heartburn/regurgitation</title>
          <description>The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
This subscale accessed the following 7 symptoms -&#xD;
Heartburn during day&#xD;
Regurgitation during day&#xD;
Heartburn when lying&#xD;
Regurgitation when lying&#xD;
Chest discomfort during day&#xD;
Bitter taste in mouth&#xD;
Chest discomfort at night&#xD;
The computed score is an average of all these gastrointestinal symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.73" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Nausea/vomiting</title>
          <description>The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
This subscale accessed the following 3 symptoms -&#xD;
Nausea&#xD;
Retching&#xD;
Vomiting&#xD;
The computed score is an average of all these gastrointestinal symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.85" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Fullness/early satiety</title>
          <description>The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
This subscale accessed the following 4 symptoms -&#xD;
Stomach fullness&#xD;
Loss of appetite&#xD;
Not able to finish meal&#xD;
Excessively full after meal&#xD;
The computed score is an average of all these gastrointestinal symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.22" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Bloating</title>
          <description>The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
This subscale accessed the following 2 symptoms -&#xD;
Bloating&#xD;
Stomach visibly larger&#xD;
The computed score is an average of all these gastrointestinal symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.67" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Upper abdominal pain</title>
          <description>The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
This subscale accessed the following 2 symptoms -&#xD;
Upper abdominal pain&#xD;
Upper abdominal discomfort&#xD;
The computed score is an average of all these gastrointestinal symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.5" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Lower abdominal pain</title>
          <description>The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
This subscale accessed the following 2 symptoms -&#xD;
Lower abdominal pain&#xD;
Lower abdominal discomfort&#xD;
The computed score is an average of all these gastrointestinal symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.83" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gastric emptying time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="323" spread="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small bowel transit time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="505" spread="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colonic transit time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2503" spread="1592"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small bowel and colonic transit time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2835" spread="1556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Whole gut transit time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3160" spread="1533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stomach Contractions</title>
          <units>Contractions/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.06" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stomach Mean Pressure</title>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.44" spread="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stomach High Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="313.82" spread="53.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stomach Low pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stomach Median pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.21" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stomach High pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.48" spread="3.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gastric Antrum Motility Index</title>
          <description>Gastric antrum is the wider part of the pylorus. It resides upstream from the pyloric canal and downstream from the stomach.&#xD;
Gastric antral motility index = sum of amplitudes × number of contractions + 1.&#xD;
The average motility index in normal subjects is approximately 11. Higher values indicate either increased contractions or increased amplitudes or both. Lower values indicate either decreased contractions or decreased amplitudes or both.</description>
          <units>index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.68" spread="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antrum Contractions</title>
          <units>Contractions/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.4" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antrum Mean Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.89" spread="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antrum High Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="271.94" spread="104.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antrum Low pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.76" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antrum Median pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.13" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antrum High pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.67" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duodenum Motility Index</title>
          <description>Duodenal motility index = sum of amplitudes × number of contractions + 1. Higher values indicate either increased contractions or increased amplitudes or both. Lower values indicate either decreased contractions or decreased amplitudes or both.</description>
          <units>index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.84" spread="22.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duodenum Contractions</title>
          <units>Contractions/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.13" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duodenum Mean Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.52" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duodenum High Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87.07" spread="59.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duodenum Low pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.33" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duodenum Median pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.30" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duodenum High pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.07" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small Bowel Contractions</title>
          <units>Contractions/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.88" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small Bowel Mean Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.03" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small Bowel High Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="143.67" spread="88.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small Bowel Low pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.32" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small Bowel Median pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.36" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Small Bowel High pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.89" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colon Contractions</title>
          <units>Contractions/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.10" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colon Mean Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.29" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colon High Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="177.84" spread="108.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colon Low pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.19" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colon Median pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.44" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colon High pH</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.41" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill</title>
        <description>If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to &lt; 6hrs, then patient would be considered a responder and that lanreotide is efficacious.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lanreotide</title>
            <description>Open label&#xD;
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill</title>
          <description>If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to &lt; 6hrs, then patient would be considered a responder and that lanreotide is efficacious.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Gastric emptying time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371.52" spread="45.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Small bowel transit time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="392" spread="47.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colonic transit time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4767" spread="1286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Small bowel and Colonic transit time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5159" spread="1284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole gut transit time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5530" spread="1322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Symptoms as Accessed by &quot;Patient Assessment of Upper GastroIntestinal Symptom Severity Index&quot;</title>
        <description>Improvement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms.&#xD;
The participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
PAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lanreotide</title>
            <description>Open label&#xD;
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Symptoms as Accessed by &quot;Patient Assessment of Upper GastroIntestinal Symptom Severity Index&quot;</title>
          <description>Improvement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms.&#xD;
The participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.&#xD;
PAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Heartburn/regurgitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.48" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea/vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fullness/early satiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.36" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.43" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lower abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month after last dose, up to 4 months from the start for each subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lanreotide</title>
          <description>Open label&#xD;
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart</description>
        </group>
      </group_list>
      <serious_events>
        <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="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="2" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Difficulty swallowing wireless motility capsule pill</sub_title>
                <description>One patient had difficulty in swallowing the wireless motility capsule and had a sensation that it was struck in the throat. Upon additional examination the subject was fine and was sent home.</description>
                <counts group_id="E1" events="9" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Unable to acknowledge the passage of the wireless motility capsule through the feces</sub_title>
                <description>Subject was not able to acknowledge the passage of the wireless motility capsule through the feces after the end of 4 days after ingestion. An abdominal x-ray was performed to confirm that the capsule was indeed expelled.</description>
                <counts group_id="E1" events="9" subjects_affected="1" subjects_at_risk="9"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This is a pilot non-randomized study in relatively small number of subjects to identify if Lanreotide will help in alleviating the symptoms and and change gut motility in patients suffering from small bowel motility disorders. A larger study randomized study is required to confirm the findings in this study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr.Larry Miller</name_or_title>
      <organization>Northwell health</organization>
      <phone>5165620334</phone>
      <email>lmiller7@northwell.edu</email>
    </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/NCT03012594
org study id: HS16-0465
nct id: NCT03012594
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a human research study looking at the effectiveness of Lanreotide (study medication)
      in treating small bowel motility disorders. It is similar to a natural hormone somatostatin
      that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a
      growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting
      medication that is given once a month. It is marketed with a trade name "Somatuline Depot".
      It is given deep subcutaneously (deep within the layers of the skin) in the superior external
      quadrant of the buttock. Injection site will be alternated on subsequent injections.
The investigators hypothesize that in patients with small bowel motility disorders,
      Lanreotide helps in alleviating the symptoms. Lanreotide is an FDA approved medication for
      management of acromegaly and neuroendocrine tumors, but has never been used for treating
      small bowel motility disorders. However, Octreotide which is similar to Lanreotide but is a
      short acting synthetic somatostatin has been used in few research studies.

      If a patient is interested and qualifies for the study then he/she will be explained about
      the study and signature will be collected on the consent form. Health and social history will
      be collected. Blood work, urine analysis, pregnancy test (in women of reproductive age group
      and have the capability of getting pregnant)) will be performed to make sure that patient
      qualifies for the study and for follow-up during the treatment. Physical examination, ECG,
      wireless motility capsule testing and hydrogen breath testing will be performed. Patients
      will be required to complete a questionnaire regarding their health.

      The total study duration from the first administration of study drug is 12 weeks. The study
      medication will be given once a month for 3 months and there is a 1 month follow-up after the
      last study medication. There will be a screening visit approximately 1 month before the first
      study drug administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
time frame: 3 months
description: If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to < 6hrs, then patient would be considered a responder and that lanreotide is efficacious.
measure: Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
time frame: 3 months
description: Improvement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms.
The participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.
PAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.
arm group label: Lanreotide
arm group type: Experimental
description: Open label
intervention type: Drug
intervention name: Lanreotide
description: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
arm group label: Lanreotide
other name: Somatuline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Larry Miller, M.D.
role: Principal Investigator
affiliation: Northwell Health
facility: 
facility: 
country: United States
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PMID: 1944424
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PMID: 8206395
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PMID: 9692691
citation: Faure C, Goulet O, Ategbo S, Breton A, Tounian P, Ginies JL, Roquelaure B, Despres C, Scaillon M, Maurage C, Paquot I, Hermier M, De Napoli S, Dabadie A, Huet F, Baudon JJ, Larchet M. Chronic intestinal pseudoobstruction syndrome: clinical analysis, outcome, and prognosis in 105 children. French-Speaking Group of Pediatric Gastroenterology. Dig Dis Sci. 1999 May;44(5):953-9. doi: 10.1023/a:1026656513463.
PMID: 10235603
citation: Stanghellini V, Cogliandro RF, de Giorgio R, Barbara G, Salvioli B, Corinaldesi R. Chronic intestinal pseudo-obstruction: manifestations, natural history and management. Neurogastroenterol Motil. 2007 Jun;19(6):440-52. doi: 10.1111/j.1365-2982.2007.00902.x.
PMID: 17564625
citation: Mann SD, Debinski HS, Kamm MA. Clinical characteristics of chronic idiopathic intestinal pseudo-obstruction in adults. Gut. 1997 Nov;41(5):675-81. doi: 10.1136/gut.41.5.675.
PMID: 9414977
citation: Lybaert W. The use of lanreotide autogel(R) in the treatment of intestinal obstruction in a patient with adenocarcinoma. Case Rep Oncol. 2014 Jan 16;7(1):43-6. doi: 10.1159/000358124. eCollection 2014 Jan.
PMID: 24575015
citation: Lamrani A, Vidon N, Sogni P, Nepveux P, Catus F, Blumberg J, Chaussade S. Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans. Br J Clin Pharmacol. 1997 Jan;43(1):65-70. doi: 10.1111/j.1365-2125.1997.tb00034.x.
PMID: 9056054
citation: Camilleri M. Small bowel motility disorders. Rev Gastroenterol Mex. 1994 Apr-Jun;59(2):120-6.
PMID: 7991964
citation: Wang C, Xu H, Chen H, Li J, Zhang B, Tang C, Ghishan FK. Somatostatin stimulates intestinal NHE8 expression via p38 MAPK pathway. Am J Physiol Cell Physiol. 2011 Feb;300(2):C375-82. doi: 10.1152/ajpcell.00421.2010. Epub 2010 Nov 24.
PMID: 21106692
citation: Giustina A, Chanson P, Bronstein MD, Klibanski A, Lamberts S, Casanueva FF, Trainer P, Ghigo E, Ho K, Melmed S; Acromegaly Consensus Group. A consensus on criteria for cure of acromegaly. J Clin Endocrinol Metab. 2010 Jul;95(7):3141-8. doi: 10.1210/jc.2009-2670. Epub 2010 Apr 21.
PMID: 20410227
citation: Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.
PMID: 20195905
citation: Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.
PMID: 15354277
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PMID: 15651544
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PMID: 15479666
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PMID: 23831693
citation: Goulet O, Sauvat F, Jan D. Surgery for pediatric patients with chronic intestinal pseudo-obstruction syndrome. J Pediatr Gastroenterol Nutr. 2005 Sep;41 Suppl 1:S66-8. doi: 10.1097/01.scs.0000180312.55417.8e. No abstract available.
PMID: 16131977
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Larry Miller
investigator title: Chief of Gastroenterology
mesh term: Intestinal Diseases
mesh term: Lanreotide
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This is a pilot non-randomized study in relatively small number of subjects to identify if Lanreotide will help in alleviating the symptoms and and change gut motility in patients suffering from small bowel motility disorders. A larger study randomized study is required to confirm the findings in this study.
point of contact: 