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Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

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ClinicalTrials.gov Identifier: NCT02970968
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: VLY-686 (Tradipitant) Other: Placebo Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Drug
VLY-686 (Tradipitant) oral capsule for 4 weeks.
Drug: VLY-686 (Tradipitant)
oral capsule

Placebo Comparator: Placebo
Placebo oral capsule for 4 weeks.
Other: Placebo
placebo oral




Primary Outcome Measures :
  1. Change in gastroparesis associated symptoms as assessed by patient reported diary [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with gastroparesis;
  2. Subjects must agree to the use of contraception
  3. Ability and acceptance to provide written informed consent;
  4. Willing to participate in the pharmacogenomics sample collection;
  5. Willing and able to comply with all study requirements and restrictions
  6. Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion Criteria:

  1. Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);
  2. Pregnancy or nursing;
  3. History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
  4. Use of another NK1 antagonist or palonosetron;
  5. Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
  6. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970968


Contacts
Contact: Vanda Pharmaceuticals 202-734-3400

  Hide Study Locations
Locations
United States, Alabama
Vanda Investigational Site Recruiting
Dothan, Alabama, United States, 36305
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Huntsville, Alabama, United States, 35801
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Arizona
Vanda Investigational Site Recruiting
Tucson, Arizona, United States, 85712
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Arkansas
Vanda Investigational Site Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, California
Vanda Investigational Site Recruiting
Chula Vista, California, United States, 91910
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Los Angeles, California, United States, 90095
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Palo Alto, California, United States, 94305
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
San Francisco, California, United States, 94115
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Florida
Vanda Investigational Site Recruiting
Jacksonville, Florida, United States, 32256
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Largo, Florida, United States, 33777
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Miami, Florida, United States, 33134
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Georgia
Vanda Investigational Site Recruiting
Athens, Georgia, United States, 30607
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Illinois
Vanda Investigational Site Recruiting
Elgin, Illinois, United States, 60123
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Indiana
Vanda Investigational Site Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Kentucky
Vanda Investigational Site Recruiting
Louisville, Kentucky, United States, 40202
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Louisiana
Vanda Investigational Site Recruiting
Marrero, Louisiana, United States, 70072
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Maryland
Vanda Investigational Site Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Massachusetts
Vanda Investigational Site Recruiting
Boston, Massachusetts, United States, 02114
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Michigan
Vanda Investigational Site Recruiting
Wyoming, Michigan, United States, 49519
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Minnesota
Vanda Investigational Site Recruiting
Minneapolis, Minnesota, United States, 55114
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Mississippi
Vanda Investigational Site Recruiting
Pascagoula, Mississippi, United States, 39564
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Missouri
Vanda Investigational Site Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, New York
Vanda Investigational Site Recruiting
Great Neck, New York, United States, 11023
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
New York, New York, United States, 10028
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, North Carolina
Vanda Investigational Site Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Salisbury, North Carolina, United States, 28144
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Ohio
Vanda Investigational Site Recruiting
Huber Heights, Ohio, United States, 45424
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Mentor, Ohio, United States, 44060
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Oklahoma
Vanda Investigational Site Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Pennsylvania
Vanda Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Tennessee
Vanda Investigational Site Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Jackson, Tennessee, United States, 38305
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Nashville, Tennessee, United States, 37211
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Texas
Vanda Investigational Site Recruiting
El Paso, Texas, United States, 79905
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Richardson, Texas, United States, 75082
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Virginia
Vanda Investigational Site Recruiting
Norfolk, Virginia, United States, 23502
Contact: Vanda Pharmaceuticals    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02970968     History of Changes
Other Study ID Numbers: VP-VLY-686-2301
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms