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

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: itopride and polyethylene glycol electrolyte solutions; Drug: Polyethylene glycol electrolyte solutions

• Registration Number: NCT01513811
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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 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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group PEG+Itp	itopride and polyethylene glycol electrolyte solutions	Patients in group were assigned to itopride half hour before administration of lavage solution in the morning of examination day.
group PEG+4Itp	itopride and polyethylene glycol electrolyte solutions	Patients in this group received itopride three times 24 hours before the examination day and another time 30 min before administration of lavage solution.
group PEG	Polyethylene glycol electrolyte solutions	This group is set as a control group and received 2 packets of Polyethylene glycol electrolyte solutions on the morning of the examination day as us we usually done.

Primary Outcome Measures

Name	Time	Method
the quality of bowel preparation	the day of colonoscopy examination	the Boston Bowel Preparation Scale (BBPS): the colon was divided into 3 broad segments: the right side (the cecum and ascending colon), the middle section (the hepatic flexures, transverse colon and splenic flexures), and the left side of the colon (the descending colon, sigmoid colon, and rectum). Each region of the colon receives a score from 0 to 3 as summarized in table 1, score 0 was considered poor preparation while score 3 indicated good cleaning quality. And these segment scores are summed for a total BBPS score ranged from 0 to 9.

Secondary Outcome Measures

Name	Time	Method
time of examination	the day of examination	Time of examination includes caecal intubation time and withdrawal time. Caecal intubation time defined as the time passing the colonoscope to the ileocaecal valve. Withdrawal time defined as the time withdrawing from ileocaecal junction to anus.
intestinal bubble scale	the day of colonoscopy examination	The scores of intestinal bubble were categorized into three levels: 0, no or nearly no bubble present; 1, small amounts of bubbles that could be washed away easily; 2, multiple collections of bubbles that could be washed away with volumes of water.
times of defecation	the day before and the day of examination	The times of defecation during the preparation were obtained and analyzed.

Trial Locations

Locations (1)

Shanghai Jiao-Tong University School of Medicine Renji Hospital; 🇨🇳 Shanghai, Shanghai, China