drugset / Trial / NCT01513811

Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective

NCT01513811

Phase 2 Completed 115 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupSingle-blindTreatment

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 number of patients, especially those constipated patients, failed colonoscopies due to poor bowel cleaning. Inadequate preparation may also lead to missed colonic lesions. The study is based on the hypothesis: itopride hydrochloride, a prokinetic agent, its dual role as dopamine D2 receptor antagonism and acetylcho-linesterase inhibition make it an appropriate adjuvant for bowel preparation. It was reported to promote colonic peristalsis, shorten colonic transit time and accelerate propulsion of colonic luminal contents through inhibition of M3 receptor and dopamine D2 receptors in vitro and in vivo. So this study is to determine the efficacy, tolerance and safety of high dose of itopride, when given in different times before administration of PEG-E, for colonic preparation in patients with chronic constipation.

Timeline

Start
2010-02
Primary completion
2011-11
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Itopride Small molecule 150 mg
Comparator Polyethylene glycol electrolyte solutions Unknown

Indications