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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinitapride | Drug | cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of overall symptom improvement after 4-weeks treatment | 4 weeks |
| Measure | Description | 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 | |
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Inclusion:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui medical university | Hefei | Anhui | China | |||
| Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24440931 | Derived | 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. |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C045316 | cinitapride |
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| domperidone |
| Drug |
10 mg for each dose ,30 mg/daily, for 4 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 |
| 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 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |