Dyspepsia
Conditions
Keywords
Cinitapride, efficacy, safety, mild to moderate functional dyspepsia
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.
Interventions
DRUGCinitapride
cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
DRUGdomperidone
10 mg for each dose ,30 mg/daily, for 4 weeks
Sponsors
Eisai China Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of overall symptom improvement after 4-weeks treatment | 4 weeks |
Secondary
| 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 |
Countries
China
Outcome results
None listed