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

Eisai

Status and phase: Completed; Phase 3

Conditions: Dyspepsia

Treatments: Drug: domperidone; Drug: Cinitapride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01355276

CYWC100602

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Cinitapride

2

Active Comparator group

Treatment:

Drug: domperidone