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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355276
• Other study ID #: CYWC100602
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2011
• Last updated: November 29, 2011
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: SFDA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Cinitapride
cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
• domperidone
10 mg for each dose ,30 mg/daily, for 4 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai China Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of overall symptom improvement after 4-weeks treatment		4 weeks	No
Secondary	Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment		2 and 4 weeks	No
Secondary	Response rate after 2 weeks treatment		2 weeks	No
Secondary	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	No
Secondary	Changes of gastric emptying in some patients after 4-week treatment		4 weeks	No
Secondary	Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment		2 and 4 weeks	No