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Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01355276
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : November 30, 2011
Information provided by (Responsible Party):
Eisai Inc. ( Eisai China Inc. )

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Cinitapride Drug: domperidone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
Drug Information available for: Domperidone

Arm Intervention/treatment
Experimental: 1 Drug: Cinitapride
cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks

Active Comparator: 2 Drug: domperidone
10 mg for each dose ,30 mg/daily, for 4 weeks

Primary Outcome Measures :
  1. Response rate of overall symptom improvement after 4-weeks treatment [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment [ Time Frame: 2 and 4 weeks ]
  2. Response rate after 2 weeks treatment [ Time Frame: 2 weeks ]
  3. 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 ]
  4. Changes of gastric emptying in some patients after 4-week treatment [ Time Frame: 4 weeks ]
  5. Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment [ Time Frame: 2 and 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01355276

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China, Anhui
The First Affiliated Hospital of Anhui medical university
Hefei, Anhui, China
China, Hubei
Huazhong University of Science and Technology of Tongji Hospital Affiliated Tongji Medical School
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
China, Jiangsu
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
Sponsors and Collaborators
Eisai China Inc.
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Principal Investigator: Zhaoshen Li Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eisai China Inc. Identifier: NCT01355276    
Other Study ID Numbers: CYWC100602
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: November 2011
Keywords provided by Eisai Inc. ( Eisai China Inc. ):
mild to moderate functional dyspepsia
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents