Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
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
1 other identifier
interventional
400
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 30, 2011
November 1, 2011
8 months
May 16, 2011
November 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate of overall symptom improvement after 4-weeks treatment
4 weeks
Secondary Outcomes (5)
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
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai China Inc.lead
Study Sites (13)
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
Related Publications (1)
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.
PMID: 24440931DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li
Changhai Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 18, 2011
Study Start
October 1, 2010
Primary Completion
June 1, 2011
Study Completion
October 1, 2011
Last Updated
November 30, 2011
Record last verified: 2011-11