NCT02970968

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DRUG	VLY-686 (Tradipitant)	oral capsule
OTHER	Placebo	placebo oral

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2016-11-22
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

38 sites across 1 country: United States