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

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: Cinitapride; Drug: domperidone

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Changzheng Hospital
  • Shanghai, China
    • Changhai Hospital
  • Suzhou, China
    • The Second Affiliated Hospital of Suzhou University
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Tianjin, China
    • The Second Hospital of Tianjin Medical University
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Changzhou First People?s Hospital
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
    • Wuxi, Jiangsu, China
      • Wuxi No.2 People's Hospital
    • Wuxi, Jiangsu, China
      • Wuxi People's Hospital
    • Yangzhou, Jiangsu, China
      • Yangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

1. Aged between 18~65 years, both males and females;
2. Patients with symptoms of mild to moderate functional dyspepsia;
3. Symptoms related to dyspepsia were developed 6 months ago and early satiety or/and discomfort after meal were developed in the past 3 months;
4. Gastrointestinal malignancy, peptic ulcer, liver, gallbladder and pancreas diseases were excluded through gastroscopy, B-ultrasonography and laboratory examination within 4 weeks prior to administration (endoscopy results considered to be clinically unrelated will not be excluded, such as small hiatal hernia and chronic nonatrophic pangastritis);
5. Patient has signed informed consent form.

Exclusion criteria

1. Patients with gastroesophageal reflux and/or irritable bowel syndrome;
2. Acid regurgitation more than once per week;
3. Previously received abdominal surgery (except appendectomy and herniorrhaphy);
4. A history of gastric or duodenal ulcer;
5. Patients with depression and anxiety neurosis;
6. Patients with arrhythmia;
7. QTc more than 0.5s;
8. Hepatic and renal insufficiency: AST or/and ALT equal to or above 1.5 times of the upper normal limit; Cr above the upper normal limit;
9. Pathological lactorrhea;
10. Patients with alcohol abuse (daily alcohol intake more than 40g), drug dependence or neuropsychiatric disorders that are difficult to control, as well as others who are not appropriate to participate in a drug trial;
11. Pregnant or lactating women;
12. Patients who require other therapy to change gastrointestinal mobility;
13. Patients who are participating or participated in other drug clinical trial within 3 months prior to entry;
14. Known to be allergic to cinitapride; Patients who are considered by investigators to be inappropriate to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Cinitapride; cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
Active Comparator: 2	Drug: domperidone; 10 mg for each dose ,30 mg/daily, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate of overall symptom improvement after 4-weeks treatment	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eisai China Inc.
• Investigators: Principal Investigator: Zhaoshen Li, Changhai Hospital

Publications and helpful links

General Publications

• Du Y, Su T, Song X, Gao J, Zou D, Zuo C, Xie W, Wang B, Zhang Z, Xu J, Tian D, Luo H, Zhang Z, Wang S, Chen J, Guo J, Gong L, Ding Y, Li Z. Efficacy and safety of cinitapride in the treatment of mild to moderate postprandial distress syndrome-predominant functional dyspepsia. J Clin Gastroenterol. 2014 Apr;48(4):328-35. doi: 10.1097/MCG.0000000000000033.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Estimate): November 30, 2011
• Last Update Submitted That Met QC Criteria: November 29, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: safety; efficacy; Cinitapride; mild to moderate functional dyspepsia
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Anti-Ulcer Agents; Domperidone; Cinitapride
• Other Study ID Numbers: CYWC100602