Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
NCT ID: NCT01355276
Last Updated: 2011-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2010-10-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Cinitapride
cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
2
domperidone
10 mg for each dose ,30 mg/daily, for 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai China Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhaoshen Li
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Anhui medical university
Hefei, Anhui, 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
Changzhou First People?s Hospital
Changzhou, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Yangzhou First People's Hospital
Yangzhou, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CYWC100602
Identifier Type: -
Identifier Source: org_study_id