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

Phase 3

Completed

• Conditions: Dyspepsia
• Interventions: Drug: Cinitapride; Drug: domperidone

• Registration Number: NCT01355276
• Lead Sponsor: Eisai China Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-29
• Last Update Posted: 2011-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cinitapride	-
2	domperidone	-

Primary Outcome Measures

Name	Time	Method
Response rate of overall symptom improvement after 4-weeks treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment	2 and 4 weeks
Response rate after 2 weeks treatment	2 weeks
Percentage change of individual symptom score (early satiety, discomfort with fullness after meal, flatulence, epigastric pain, epigastric burning, nausea, vomiting and belching) after 2 and 4 weeks treatment compared with the baseline	2 and 4 weeks
Changes of gastric emptying in some patients after 4-week treatment	4 weeks
Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment	2 and 4 weeks

Trial Locations

Locations (13)

Wuxi People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Yangzhou First People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China

The Second Hospital of Tianjin Medical University; 🇨🇳 Tianjin, China

The First Affiliated Hospital of Anhui medical university; 🇨🇳 Hefei, Anhui, China

Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School; 🇨🇳 Wuhan, Hubei, China

Changzhou First People?s Hospital; 🇨🇳 Changzhou, Jiangsu, China

Wuxi No.2 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Changhai Hospital; 🇨🇳 Shanghai, China

The Second Affiliated Hospital of Suzhou University; 🇨🇳 Suzhou, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China