MedTrace Logo

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

NCT01355276 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-11-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Eisai China Inc.

    lead INDUSTRY

Principal Investigators

  • Zhaoshen Li · Changhai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-06-30
Completion
2011-10-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01355276 on ClinicalTrials.gov