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

NCT ID: NCT01513811

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-12-31

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group PEG

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.

Group Type: ACTIVE_COMPARATOR

Polyethylene glycol electrolyte solutions

Intervention Type: 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.

group PEG+Itp

Patients in group were assigned to itopride half hour before administration of lavage solution in the morning of examination day.

Group Type: ACTIVE_COMPARATOR

Itopride and Polyethylene glycol electrolyte solutions

Intervention Type: 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.

group PEG+4Itp

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 Type: ACTIVE_COMPARATOR

itopride and polyethylene glycol electrolyte solutions

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

PEG-E; PEG-E; Itopride hydrochloride; PEG-E; itopride hydrochloride

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Li

Xiaobo Li

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li X B, M.D., Ph.D.

Role: STUDY_CHAIR

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Locations

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

rjyyxhk0906

Identifier Type: -

Identifier Source: org_study_id