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

NCT01513811 | Completed Phase 2

• 1 other identifier: rjyyxhk0906
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

bowel preparation; constipation; polyethylene glycol; itopride

Outcome Measures

Primary Outcomes (1)

• 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 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.

  the day of colonoscopy examination

Secondary Outcomes (3)

• intestinal bubble scale

  the day of colonoscopy examination

• time of examination

  the day of examination

• times of defecation

  the day before and the day of examination

Study Arms (3)

group PEG

ACTIVE COMPARATOR

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.

Drug: Polyethylene glycol electrolyte solutions

group PEG+Itp

ACTIVE COMPARATOR

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

Drug: Itopride and Polyethylene glycol electrolyte solutions

group PEG+4Itp

ACTIVE COMPARATOR

Patients in this group received itopride three times 24 hours before the examination day and another time 30 min before administration of lavage solution.

Drug: itopride and polyethylene glycol electrolyte solutions

Interventions

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.

Also known as: PEG-E

group PEG

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.

Also known as: PEG-E, Itopride hydrochloride

group PEG+Itp

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao-Tong University School of Medicine Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Constipation

Interventions

itopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Li X B, M.D., Ph.D.

  Shanghai Jiao-Tong University School of Medicine Renji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiaobo Li

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

CN (1)