NCT01355276

Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

A Randomized, Double-blind, Double-dummy, Active Drug Parallel Controlled, Multi-center Clinical Trial on the Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Eisai China Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare Cinitapride tablets with domperidone tablets (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment of mild to moderate functional dyspepsia.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Cinitapride	cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
DRUG	domperidone	10 mg for each dose ,30 mg/daily, for 4 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-06-01
• Completion: 2011-10-01
• First posted: 2011-05-18
• Last updated: 2011-11-30

Locations

13 sites across 1 country: China