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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaobo Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01513811
First received: January 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Constipation
 Drug: Polyethylene glycol electrolyte solutions
Drug: Itopride and Polyethylene glycol electrolyte solutions
Drug: itopride and polyethylene glycol electrolyte solutions
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose of Itopride: a Valid Adjuvant for Bowel Preparation in Patients With Chronic Constipation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • the quality of bowel preparation [ Time Frame: the day of colonoscopy examination ] [ Designated as safety issue: No ]
    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:
  • intestinal bubble scale [ Time Frame: the day of colonoscopy examination ] [ Designated as safety issue: No ]
    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.

  • time of examination [ Time Frame: the day of examination ] [ Designated as safety issue: No ]
    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.

  • times of defecation [ Time Frame: the day before and the day of examination ] [ Designated as safety issue: No ]
    The times of defecation during the preparation were obtained and analyzed.


Enrollment: 115
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 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.
Other Name: PEG-E
Active Comparator: group PEG+Itp
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
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
Active Comparator: 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.
 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.
Other Names:
  • PEG-E
  • itopride hydrochloride

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513811

Locations
China, Shanghai
Shanghai Jiao-Tong University School of Medicine Renji Hospital
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Chair: Li X B, M.D., Ph.D. Shanghai Jiao-Tong University School of Medicine Renji Hospital
  More Information

No publications provided

Responsible Party: Xiaobo Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01513811     History of Changes
Other Study ID Numbers: rjyyxhk0906
Study First Received: January 16, 2012
Last Updated: April 17, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
bowel preparation
constipation
polyethylene glycol
itopride

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Citric Acid
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013