Status:
COMPLETED
Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Constipation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Bowel preparation is a major determinant of colonoscopy and colorectal surgery. Polyethylene glycol electrolyte solutions (PEG-E) are the most commonly used laxatives in China. However, a significant ...
Detailed Description
Colonoscopy is a reliable procedure for the investigation of colonic and distal terminal ileum disease. The diagnostic accuracy of colonoscopy is dependent on visualization of the colonic mucosa; henc...
Eligibility Criteria
Inclusion
- Patients suspected colonic disease and suffered from chronic constipation were referred for colonoscopy and enrolled in the study. Chronic constipation was diagnosed on the basis of Rome III criteria.Suspected colonic disease was defined as:
- recent change of bowel habits;
- obscure GI bleeding (hemafecia, melena or positive fecal occult blood test);
- obscure abdominal pain;
- weight loss;
- positive findings in the colon on GI imaging;
- serological test referred to colorectal cancer such as CEA elevated obviously;
- family history of colorectal cancer or adenomatous polyps.
Exclusion
- usage of prokinetic agents such as itopride, mosapride within 4 weeks and tricyclic antidepressants 8 weeks prior to entering the protocol;
- known allergies or other contraindication to PEG or itopride;
- a history of abdominal surgery or bowel obstruction;
- pregnant or lactating;
- conditions associated with severe cardiac, hepatic, or renal impairment.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01513811
Start Date
February 1 2010
End Date
December 1 2011
Last Update
April 19 2012
Active Locations (1)
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1
Shanghai Jiao-Tong University School of Medicine Renji Hospital
Shanghai, Shanghai Municipality, China, 200001