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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai China Inc. )
ClinicalTrials.gov Identifier:
NCT01355276
First received: May 16, 2011
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Dyspepsia
Drug: Cinitapride
Drug: domperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Response rate of overall symptom improvement after 4-weeks treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Response rate after 2 weeks treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes of gastric emptying in some patients after 4-week treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355276

Locations
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 People's Hospital
Wuxi, Jiangsu, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China
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.
Investigators
Principal Investigator: Zhaoshen Li Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc. ( Eisai China Inc. )
ClinicalTrials.gov Identifier: NCT01355276     History of Changes
Other Study ID Numbers: CYWC100602
Study First Received: May 16, 2011
Last Updated: November 29, 2011
Health Authority: China: SFDA

Keywords provided by Eisai Inc.:
Cinitapride
efficacy
safety
mild to moderate functional dyspepsia

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014