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NCT02970968 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
A Phase 2 study of Gastroparesis, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT02970968: Completed Phase 2 study of Gastroparesis, sponsored by Vanda Pharmaceuticals.
NCT02970968 is a Phase 2 study of Gastroparesis that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 152 participants, below the 299-participant average among 44 other Gastroparesis trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02970968, a Phase 2 study of Gastroparesis, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the
Conditions Studied
Interventions
- OTHER Placebo
- DRUG VLY-686 (Tradipitant)
Study Locations (20)
California
- Vanda Investigational Site - Chula Vista
- Vanda Investigational Site - Los Angeles
- Vanda Investigational Site - Palo Alto
- Vanda Investigational Site - San Francisco
Florida
- Vanda Investigational Site - Jacksonville
- Vanda Investigational Site - Largo
- Vanda Investigational Site - Miami
Alabama
- Vanda Investigational Site - Dothan
- Vanda Investigational Site - Huntsville
Massachusetts
- Vanda Investigational Site - Boston
- Vanda Investigational Site - Boston
Arizona
- Vanda Investigational Site - Tucson
Arkansas
- Vanda Investigational Site - Little Rock
Georgia
- Vanda Investigational Site - Athens
Illinois
- Vanda Investigational Site - Elgin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-12 |
| Phase | Phase 2 |
What the finished NCT02970968 record still lists
NCT02970968 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 299-participant average among 44 other Gastroparesis trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02970968 names 20 study sites across 13 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02970968 about?
NCT02970968 is a clinical study titled "Study to Assess the Efficacy of VLY-686 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.
What is the current status of trial NCT02970968?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2016-11. Estimated completion is 2018-12.
What conditions does trial NCT02970968 study?
This clinical trial studies the following conditions: Gastroparesis.
What interventions are being tested in trial NCT02970968?
The interventions under investigation include: Placebo (OTHER), VLY-686 (Tradipitant) (DRUG).
Who is sponsoring clinical trial NCT02970968?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02970968 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02970968's enrollment target sits among peer trials
152 14th of 44 higher than 31 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
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