<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/NCT01712412</url>
  </required_header>
  <id_info>
    <org_study_id>ICP-112-201</org_study_id>
    <nct_id>NCT01712412</nct_id>
  </id_info>
  <brief_title>Phase 2a Study of IW-9179 to Treat Functional Dyspepsia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ironwood Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ironwood Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to determine the safety and efficacy of IW-9179 administered&#xD;
      to patients with functional dyspepsia (FD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow enrollment&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of treatment-emergent adverse events</measure>
    <time_frame>Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment</measure>
    <time_frame>Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)</measure>
    <time_frame>Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)</measure>
    <time_frame>Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-meal Symptom Severity (PMSS) Assessment</measure>
    <time_frame>Completed at day 1 and day 14 of the Treatment Period</time_frame>
    <description>Assessments completed at 15 min prior to dose, just prior to dose, and every 15 minutes after the first dose through 240 minutes (4 hours after first dose)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Patient Symptom Severity (PSS) Assessment</measure>
    <time_frame>Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment</time_frame>
    <description>Assessments recorded on a daily basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly Symptom Relief (SR) Assessments</measure>
    <time_frame>Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment</time_frame>
    <description>Assessments recorded on a weekly basis weekly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nepean Dyspepsia Index</measure>
    <time_frame>Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Dyspepsia</condition>
  <condition>Functional Gastrointestinal Disorders</condition>
  <arm_group>
    <arm_group_label>IW-9179</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral IW-9179 taken daily for two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral placebo taken daily for two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IW-9179</intervention_name>
    <arm_group_label>IW-9179</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient meets ROME III criteria for functional dyspepsia (FD)&#xD;
&#xD;
          -  Patient has a normal esophagogastroduodenoscopy (EGD) either during the Screening&#xD;
             Period or within 2 years of the Screening Visit&#xD;
&#xD;
          -  Patients who EITHER:&#xD;
&#xD;
               1. Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening&#xD;
                  Visit, OR&#xD;
&#xD;
               2. Have used a PPI at a stable dose for at least 4 weeks prior to the Screening&#xD;
                  Visit;&#xD;
&#xD;
          -  Patient meets symptom severity criteria in the Pretreatment Period&#xD;
&#xD;
          -  Patient is fluent and literate in Dutch, French, or English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient meets criteria for gastroesophageal reflux disease (GERD, stable regimen of&#xD;
             PPIs acceptable), constipation, diarrhea, lower abdominal pain, or gastroparesis&#xD;
&#xD;
          -  Patient has a history of inflammatory bowel disease, chronic pancreatitis, small&#xD;
             intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic&#xD;
             kidney disease, interstitial cystitis, or scleroderma&#xD;
&#xD;
          -  Any significant neurological disease or a history of cancer (resected basal cell or&#xD;
             squamous cell carcinoma of the skin is acceptable; complete remission of other cancers&#xD;
             for 5 years or longer is also acceptable)&#xD;
&#xD;
          -  History of active alcoholism or drug addiction within 12 months prior to the Screening&#xD;
             Visit&#xD;
&#xD;
          -  Hospitalized for a psychiatric condition or has made a suicide attempt during the two&#xD;
             years before the Screening Visit&#xD;
&#xD;
          -  Any organic or structural disease that can cause abdominal pain or discomfort&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AZ Sint-Lucas Brugge</name>
      <address>
        <city>Brugge</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Z.O.L. - Campus St. Jan</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ambroise Pare</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Hartziekenhuis Roselare-Menen vzw</name>
      <address>
        <city>Roselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FlevoResearch</name>
      <address>
        <city>Almere</city>
        <zip>1311 RL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PreCare Trial and Recruitment</name>
      <address>
        <city>Beek</city>
        <zip>6191 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andromed Breda</name>
      <address>
        <city>Breda</city>
        <zip>4811 SW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andromed Eindhoven</name>
      <address>
        <city>Eindhoven</city>
        <zip>5616GB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andromed Noord</name>
      <address>
        <city>Groningen</city>
        <zip>9711 SG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andromed Leiden</name>
      <address>
        <city>Leiden</city>
        <zip>2352 RA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Med Ctr</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andromed Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <zip>3021 HC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>March 18, 2014</last_update_submitted>
  <last_update_submitted_qc>March 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01712412
org study id: ICP-112-201
nct id: NCT01712412
lead sponsor: 
has dmc: No
The objectives of this study are to determine the safety and efficacy of IW-9179 administered
      to patients with functional dyspepsia (FD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Rate of treatment-emergent adverse events
time frame: Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
measure: Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment
time frame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
measure: Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)
time frame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
measure: Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)
time frame: Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose)
measure: Post-meal Symptom Severity (PMSS) Assessment
time frame: Completed at day 1 and day 14 of the Treatment Period
description: Assessments completed at 15 min prior to dose, just prior to dose, and every 15 minutes after the first dose through 240 minutes (4 hours after first dose)
measure: Daily Patient Symptom Severity (PSS) Assessment
time frame: Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment
description: Assessments recorded on a daily basis
measure: Weekly Symptom Relief (SR) Assessments
time frame: Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
description: Assessments recorded on a weekly basis weekly
measure: Nepean Dyspepsia Index
time frame: Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)
arm group label: IW-9179
arm group type: Experimental
description: Oral IW-9179 taken daily for two weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral placebo taken daily for two weeks
intervention type: Drug
intervention name: IW-9179
arm group label: IW-9179
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Belgium
country: Netherlands
responsible party type: Sponsor
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
mesh term: Dyspepsia