Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

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.
    

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; hence an appropriate bowel preparation is essential for the examination.
      Despite multiple lavage were used throughout the years, the suboptimal cleaning level have
      been reported vary from 10% to more than 20% and up to one-third of incomplete or failed
      colonoscopies can be ascribed to poor bowel preparation. So it is important for us to search
      a new regimen for bowel preparation.
    

Intervention name(s): Polyethylene glycol electrolyte solutions; Itopride and Polyethylene glycol electrolyte solutions; itopride and polyethylene glycol electrolyte solutions
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received 2 packets of polyethylene glycol electrolyte solutions(PEG-E) without itopride.PEG-E was dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min consumed the total 2 L solution in 2 hours.6 hours later, the colonoscopy was performed.; Patients were assigned to itopride 150mg, then 30 min later they were given 2 packets of polyethylene glycol electrolyte solutions(PEG-E). PEG-E was dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min consumed the total 2 L solution in 2 hours. 6 hours later, the colonoscopy was performed.; Patients received itopride 150mg t.i.d(7am、12am、8pm) 24 hours before the examination day and another 150mg 30min before administration of polyethylene glycol electrolyte solutions(PEG-E).Two packets of PEG-E were dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min and consumed the total 2 L solution in 2 hours. 6 hours later, the colonoscopies were performed.
Other intervention name(s): PEG-E; PEG-E; Itopride hydrochloride; PEG-E; itopride hydrochloride
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bowel preparation; constipation; polyethylene glycol; itopride