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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Experimental: Study Drug
VLY-686 (Tradipitant) oral capsule for 4 weeks.
Drug: VLY-686 (Tradipitant)
Placebo Comparator: Placebo
Placebo oral capsule for 4 weeks.
- Change in gastroparesis associated symptoms as assessed by patient reported diary [ Time Frame: 4 weeks ]
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|
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