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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Cinitapride
* Drug: domperidone


Participation Criteria
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Eligibility Criteria
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Inclusion: Aged between 18 65 years, both males and females; Patients with symptoms of mild to moderate functional dyspepsia; Symptoms related to dyspepsia were developed 6 months ago and early satiety or/and discomfort after meal were developed in the past 3 months; 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); Patient has signed informed consent form. Exclusion criteria Patients with gastroesophageal reflux and/or irritable bowel syndrome; Acid regurgitation more than once per week; Previously received abdominal surgery (except appendectomy and herniorrhaphy); A history of gastric or duodenal ulcer; Patients with depression and anxiety neurosis; Patients with arrhythmia; QTc more than 0.5s; 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; Pathological lactorrhea; 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; Pregnant or lactating women; Patients who require other therapy to change gastrointestinal mobility; Patients who are participating or participated in other drug clinical trial within 3 months prior to entry; Known to be allergic to cinitapride; Patients who are considered by investigators to be inappropriate to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Cinitapride<br>* cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks<br>|
| Active Comparator: 2<br> | Drug: domperidone<br>* 10 mg for each dose ,30 mg/daily, for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cinitapride, efficacy, safety, mild to moderate functional dyspepsia