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

April 26, 2018 updated by: Vanda Pharmaceuticals

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in gastroparesis associated symptoms as assessed by patient reported diary
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (ESTIMATE)

November 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroparesis

Clinical Trials on VLY-686 (Tradipitant)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe