Back to resultsEfficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cinitapride
domperidone
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Cinitapride, efficacy, safety, mild to moderate functional dyspepsia
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Anhui medical university
- Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School
- Renmin Hospital of Wuhan University
- Changzhou First People?s Hospital
- Nanjing First Hospital
- Wuxi No.2 People's Hospital
- Wuxi People's Hospital
- Yangzhou First People's Hospital
- Changhai Hospital
- Shanghai Changzheng Hospital
- The Second Affiliated Hospital of Suzhou University
- The Second Hospital of Tianjin Medical University
- Tianjin Medical University General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Response rate of overall symptom improvement after 4-weeks treatment
Secondary Outcome Measures
Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment
Response rate after 2 weeks treatment
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
Changes of gastric emptying in some patients after 4-week treatment
Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01355276
Brief Title
Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai China Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Cinitapride, efficacy, safety, mild to moderate functional dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cinitapride
Intervention Description
cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
domperidone
Intervention Description
10 mg for each dose ,30 mg/daily, for 4 weeks
Primary Outcome Measure Information:
Title
Response rate of overall symptom improvement after 4-weeks treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment
Time Frame
2 and 4 weeks
Title
Response rate after 2 weeks treatment
Time Frame
2 weeks
Title
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
Time Frame
2 and 4 weeks
Title
Changes of gastric emptying in some patients after 4-week treatment
Time Frame
4 weeks
Title
Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment
Time Frame
2 and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui medical university
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Changzhou First People?s Hospital
City
Changzhou
State/Province
Jiangsu
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
Country
China
Facility Name
The Second Affiliated Hospital of Suzhou University
City
Suzhou
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24440931
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
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