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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513811
• Other study ID #: rjyyxhk0906
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2012
• Last updated: April 17, 2012
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 de?ned as:

• recent change of bowel habits;

• obscure GI bleeding (hemafecia, melena or positive fecal occult blood test);

• obscure abdominal pain;

• weight loss;

• positive ?ndings 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Polyethylene glycol electrolyte solutions
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.
• Itopride and Polyethylene glycol electrolyte solutions
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.
• itopride and polyethylene glycol electrolyte solutions
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.

Locations

Country	Name	City	State
China	Shanghai Jiao-Tong University School of Medicine Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quality of bowel preparation	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 ?exures, transverse colon and splenic ?exures), 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.	the day of colonoscopy examination	No
Secondary	intestinal bubble scale	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.	the day of colonoscopy examination	No
Secondary	time of examination	Time of examination includes caecal intubation time and withdrawal time. Caecal intubation time de?ned as the time passing the colonoscope to the ileocaecal valve. Withdrawal time de?ned as the time withdrawing from ileocaecal junction to anus.	the day of examination	No
Secondary	times of defecation	The times of defecation during the preparation were obtained and analyzed.	the day before and the day of examination	No