<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/NCT01718938</url>
  </required_header>
  <id_info>
    <org_study_id>0093</org_study_id>
    <nct_id>NCT01718938</nct_id>
  </id_info>
  <brief_title>Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis</brief_title>
  <official_title>A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theravance Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alfasigma S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Theravance Biopharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, double-blind, incomplete block, three period fixed&#xD;
      sequence crossover, multicenter, placebo-controlled study. The study will assess three oral&#xD;
      doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three&#xD;
      periods of 1-week duration each, with a 1-week washout period between treatment periods, in&#xD;
      subjects with diabetic or idiopathic gastroparesis.&#xD;
&#xD;
      Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic&#xD;
      gastroparesis by assessing changes in gastric emptying.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric emptying half time (GE t1/2)</measure>
    <time_frame>From baseline to week 5</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of lag time to gastric emptying (tlag)</measure>
    <time_frame>From baseline to Week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs</measure>
    <time_frame>From baseline to Day 49</time_frame>
    <description>Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECGs</measure>
    <time_frame>From baseline to Day 49</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>From baseline to Day 49</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3-way crossover of velusetrag or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3-way crossover of velusetrag or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3-way crossover of velusetrag or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3-way crossover of velusetrag or placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>velusetrag dose 1</intervention_name>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
    <other_name>TD-5108</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>velusetrag dose 2</intervention_name>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
    <other_name>TD-5108</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>velusetrag dose 3</intervention_name>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
    <other_name>TD-5108</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper&#xD;
             abdominal pain, retching or vomiting) for at least 3 months prior to Screening&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive&#xD;
&#xD;
          -  Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening&#xD;
&#xD;
          -  Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) &gt; 160&#xD;
             minutes as determined by [13C]-octanoate breath test, at Screening&#xD;
&#xD;
          -  Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging&#xD;
             reasonably proximal to the diagnosis of gastroparesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute severe gastroenteritis within 2 weeks prior to Screening&#xD;
&#xD;
          -  History of gastric outlet obstruction&#xD;
&#xD;
          -  Prior history of gastric surgery, including but not limited to gastrectomy, gastric&#xD;
             bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication&#xD;
&#xD;
          -  Recurrent vomiting, defined as vomiting more than 2 days per week&#xD;
&#xD;
          -  Hospitalization for treatment of gastroparesis or complications of diabetes within 4&#xD;
             weeks prior to Screening&#xD;
&#xD;
          -  Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal&#xD;
             thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening&#xD;
&#xD;
          -  If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level &gt;10% or a&#xD;
             glucose &gt; 250 mg/dL at Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Desert Sun Clinical Research</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axis Clinical Trials</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ventura Clinical Trials</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Associates &amp; Endoscopy Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Digestive and Liver Diseases, Inc.</name>
      <address>
        <city>Mexico</city>
        <state>Missouri</state>
        <zip>65265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Gastroenterology Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive and Liver Disease Specialists</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <disposition_first_submitted>February 22, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>February 22, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 26, 2018</disposition_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastroparesis</keyword>
  <keyword>Diabetic</keyword>
  <keyword>Idiopathic</keyword>
  <keyword>Delayed gastric emptying</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01718938
org study id: 0093
nct id: NCT01718938
lead sponsor: 
collaborator: 
has dmc: No
This is a multicenter, randomized, double-blind, incomplete block, three period fixed
      sequence crossover, multicenter, placebo-controlled study. The study will assess three oral
      doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three
      periods of 1-week duration each, with a 1-week washout period between treatment periods, in
      subjects with diabetic or idiopathic gastroparesis.

      Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic
      gastroparesis by assessing changes in gastric emptying.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gastric emptying half time (GE t1/2)
time frame: From baseline to week 5
measure: Duration of lag time to gastric emptying (tlag)
time frame: From baseline to Week 5
measure: Vital signs
time frame: From baseline to Day 49
description: Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis
measure: ECGs
time frame: From baseline to Day 49
measure: Number of adverse events
time frame: From baseline to Day 49
arm group label: Sequence 1
arm group type: Experimental
description: 3-way crossover of velusetrag or placebo
arm group label: Sequence 2
arm group type: Experimental
description: 3-way crossover of velusetrag or placebo
arm group label: Sequence 3
arm group type: Experimental
description: 3-way crossover of velusetrag or placebo
arm group label: Sequence 4
arm group type: Experimental
description: 3-way crossover of velusetrag or placebo
intervention type: Drug
intervention name: velusetrag dose 1
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
other name: TD-5108
intervention type: Drug
intervention name: velusetrag dose 2
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
other name: TD-5108
intervention type: Drug
intervention name: velusetrag dose 3
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
other name: TD-5108
intervention type: Drug
intervention name: placebo
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gastroparesis