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Completed

NCT Number: NCT01513811

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polyethylene glycol electrolyte solutions

Drug

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.

Other names: PEG-E

Itopride and Polyethylene glycol electrolyte solutions

Drug

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.

Other names: PEG-E, Itopride hydrochloride

Primary outcomes

  1. the quality of bowel preparation

    Time frame: 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 outcomes

  1. intestinal bubble scale

    Time frame: 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.

  2. time of examination

    Time frame: 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.

  3. times of defecation

    Time frame: the day before and the day of examination

    The times of defecation during the preparation were obtained and analyzed.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

High Dose of Itopride: a Valid Adjuvant for Bowel Preparation in Patients With Chronic Constipation

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2012
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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