NCT03225248

Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Multi-center, Randomized, Active-Controlled, Double-Blind, Non-Inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia (MARS Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Korea United Pharm. Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.

Detailed description

Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	UI05MSP015CT	UI05MSP015CT and Placebo of Gasmotin
DRUG	Gasmotin	Placebo of UI05MSP015CT and Gasmotin

Timeline

• Start date: 2014-11-05
• Primary completion: 2015-09-05
• Completion: 2015-10-12
• First posted: 2017-07-21
• Last updated: 2017-07-21