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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03225248
Study type Interventional
Source Korea United Pharm. Inc.
Contact
Status Completed
Phase Phase 3
Start date November 5, 2014
Completion date October 12, 2015
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