drugset / Trial / NCT01355276

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

NCT01355276 ↗

Phase 3 Completed 400 enrolled Eisai Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-10
Primary completion
2011-06
Completion
2011-10

Outcome

Met primary endpoint

paper This phase III trial has confirmed a noninferior efficacy of cinitapride over domperidone PMID 24440931 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cinitapride Small molecule 1 mg —
Comparator Domperidone Unknown 10 mg —

Indications