Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
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ClinicalTrials.gov Identifier: NCT02970968 |
Recruitment Status : Unknown
Verified April 2018 by Vanda Pharmaceuticals.
Recruitment status was: Recruiting
First Posted : November 22, 2016
Last Update Posted : April 27, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroparesis | Drug: VLY-686 (Tradipitant) Other: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Study Drug
VLY-686 (Tradipitant) oral capsule for 4 weeks.
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Drug: VLY-686 (Tradipitant)
oral capsule |
Placebo Comparator: Placebo
Placebo oral capsule for 4 weeks.
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Other: Placebo
placebo oral |
- Change in gastroparesis associated symptoms as assessed by patient reported diary [ Time Frame: 4 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with gastroparesis;
- Subjects must agree to the use of contraception
- Ability and acceptance to provide written informed consent;
- Willing to participate in the pharmacogenomics sample collection;
- Willing and able to comply with all study requirements and restrictions
- Willing to not participate in any other interventional trial for the duration of their participation.
Exclusion Criteria:
- 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);
- Pregnancy or nursing;
- History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
- Use of another NK1 antagonist or palonosetron;
- Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
- 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.

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
Contact: Vanda Pharmaceuticals | 202-734-3400 |
United States, Alabama | |
Vanda Investigational Site | Recruiting |
Dothan, Alabama, United States, 36305 | |
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Vanda Investigational Site | Recruiting |
Huntsville, Alabama, United States, 35801 | |
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United States, Arizona | |
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Tucson, Arizona, United States, 85712 | |
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United States, Arkansas | |
Vanda Investigational Site | Recruiting |
Little Rock, Arkansas, United States, 72211 | |
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United States, California | |
Vanda Investigational Site | Recruiting |
Chula Vista, California, United States, 91910 | |
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Vanda Investigational Site | Recruiting |
Los Angeles, California, United States, 90095 | |
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Vanda Investigational Site | Recruiting |
Palo Alto, California, United States, 94305 | |
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Vanda Investigational Site | Recruiting |
San Francisco, California, United States, 94115 | |
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United States, Florida | |
Vanda Investigational Site | Recruiting |
Jacksonville, Florida, United States, 32256 | |
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Vanda Investigational Site | Recruiting |
Largo, Florida, United States, 33777 | |
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Vanda Investigational Site | Recruiting |
Miami, Florida, United States, 33134 | |
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United States, Georgia | |
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Athens, Georgia, United States, 30607 | |
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United States, Illinois | |
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Elgin, Illinois, United States, 60123 | |
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United States, Indiana | |
Vanda Investigational Site | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
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United States, Kentucky | |
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Louisville, Kentucky, United States, 40202 | |
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United States, Louisiana | |
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Marrero, Louisiana, United States, 70072 | |
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United States, Maryland | |
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Chevy Chase, Maryland, United States, 20815 | |
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United States, Massachusetts | |
Vanda Investigational Site | Recruiting |
Boston, Massachusetts, United States, 02114 | |
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Vanda Investigational Site | Recruiting |
Boston, Massachusetts, United States, 02215 | |
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United States, Michigan | |
Vanda Investigational Site | Recruiting |
Wyoming, Michigan, United States, 49519 | |
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United States, Minnesota | |
Vanda Investigational Site | Recruiting |
Minneapolis, Minnesota, United States, 55114 | |
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United States, Mississippi | |
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Pascagoula, Mississippi, United States, 39564 | |
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United States, Missouri | |
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Saint Louis, Missouri, United States, 63104 | |
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United States, New York | |
Vanda Investigational Site | Recruiting |
Great Neck, New York, United States, 11023 | |
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Vanda Investigational Site | Recruiting |
New York, New York, United States, 10028 | |
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United States, North Carolina | |
Vanda Investigational Site | Recruiting |
Raleigh, North Carolina, United States, 27612 | |
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Vanda Investigational Site | Recruiting |
Salisbury, North Carolina, United States, 28144 | |
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United States, Ohio | |
Vanda Investigational Site | Recruiting |
Huber Heights, Ohio, United States, 45424 | |
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Vanda Investigational Site | Recruiting |
Mentor, Ohio, United States, 44060 | |
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United States, Oklahoma | |
Vanda Investigational Site | Recruiting |
Tulsa, Oklahoma, United States, 74104 | |
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United States, Pennsylvania | |
Vanda Investigational Site | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
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United States, Tennessee | |
Vanda Investigational Site | Recruiting |
Chattanooga, Tennessee, United States, 37421 | |
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Vanda Investigational Site | Recruiting |
Jackson, Tennessee, United States, 38305 | |
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Vanda Investigational Site | Recruiting |
Nashville, Tennessee, United States, 37211 | |
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United States, Texas | |
Vanda Investigational Site | Recruiting |
El Paso, Texas, United States, 79905 | |
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Vanda Investigational Site | Recruiting |
Houston, Texas, United States, 77030 | |
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Vanda Investigational Site | Recruiting |
Richardson, Texas, United States, 75082 | |
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United States, Virginia | |
Vanda Investigational Site | Recruiting |
Norfolk, Virginia, United States, 23502 | |
Contact: Vanda Pharmaceuticals 202-734-3400 |
Responsible Party: | Vanda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02970968 |
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 |
Gastroparesis Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Paralysis Neurologic Manifestations |