<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/NCT02970968</url>
  </required_header>
  <id_info>
    <org_study_id>VP-VLY-686-2301</org_study_id>
    <nct_id>NCT02970968</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanda Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanda Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in&#xD;
      the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy&#xD;
      the selection criteria for the study, will be randomized to one of two treatment groups,&#xD;
      active or placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in&#xD;
      the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy&#xD;
      the selection criteria for the study, will be randomized to one of two treatment groups,&#xD;
      active or placebo.&#xD;
&#xD;
      The study is divided into two phases: the screening phase and the evaluation phase. The&#xD;
      screening phase includes a screening visit to evaluate subjects' preliminary eligibility for&#xD;
      the study. During the screening phase, subjects will collect diary data for at least 4 weeks.&#xD;
      The evaluation phase includes 4 weeks of randomized double-blind treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gastroparesis associated symptoms as assessed by patient reported diary</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Study Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VLY-686 (Tradipitant) oral capsule for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral capsule for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VLY-686 (Tradipitant)</intervention_name>
    <description>oral capsule</description>
    <arm_group_label>Study Drug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo oral</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with gastroparesis;&#xD;
&#xD;
          2. Subjects must agree to the use of contraception&#xD;
&#xD;
          3. Ability and acceptance to provide written informed consent;&#xD;
&#xD;
          4. Willing to participate in the pharmacogenomics sample collection;&#xD;
&#xD;
          5. Willing and able to comply with all study requirements and restrictions&#xD;
&#xD;
          6. Willing to not participate in any other interventional trial for the duration of their&#xD;
             participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Another active disorder or treatment which could explain or contribute to symptoms in&#xD;
             the opinion of the Investigator (including but not limited to gastric malignancy,&#xD;
             neurological disorder, or heavy doses of strong anticholinergics);&#xD;
&#xD;
          2. Pregnancy or nursing;&#xD;
&#xD;
          3. History of intolerance and/or hypersensitivity to medications similar to VLY-686&#xD;
             (Tradipitant) and its accompanying excipients;&#xD;
&#xD;
          4. Use of another NK1 antagonist or palonosetron;&#xD;
&#xD;
          5. Exposure to any investigational medication, including placebo, within 60 days of the&#xD;
             Baseline Visit;&#xD;
&#xD;
          6. Any other reason as determined by the Investigator which may lead to an unfavorable&#xD;
             risk-benefit of study participation, may interfere with study compliance, or may&#xD;
             confound study results.&#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_contact>
    <last_name>Vanda Pharmaceuticals</last_name>
    <phone>202-734-3400</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33777</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Elgin</city>
        <state>Illinois</state>
        <zip>60123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>49519</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Pascagoula</city>
        <state>Mississippi</state>
        <zip>39564</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11023</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10028</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Huber Heights</city>
        <state>Ohio</state>
        <zip>45424</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75082</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2018</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>Gastroparesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02970968
org study id: VP-VLY-686-2301
nct id: NCT02970968
lead sponsor: 
has dmc: No
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in
      the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy
      the selection criteria for the study, will be randomized to one of two treatment groups,
      active or placebo.
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in
      the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy
      the selection criteria for the study, will be randomized to one of two treatment groups,
      active or placebo.

      The study is divided into two phases: the screening phase and the evaluation phase. The
      screening phase includes a screening visit to evaluate subjects' preliminary eligibility for
      the study. During the screening phase, subjects will collect diary data for at least 4 weeks.
      The evaluation phase includes 4 weeks of randomized double-blind treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in gastroparesis associated symptoms as assessed by patient reported diary
time frame: 4 weeks
arm group label: Study Drug
arm group type: Experimental
description: VLY-686 (Tradipitant) oral capsule for 4 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo oral capsule for 4 weeks.
intervention type: Drug
intervention name: VLY-686 (Tradipitant)
description: oral capsule
arm group label: Study Drug
intervention type: Other
intervention name: Placebo
description: placebo oral
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Vanda Pharmaceuticals
phone: 202-734-3400
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country: United States
responsible party type: Sponsor
mesh term: Gastroparesis
sharing ipd: No