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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Polyethylene glycol electrolyte solutions
Itopride and Polyethylene glycol electrolyte solutions
itopride and polyethylene glycol electrolyte solutions
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring bowel preparation, constipation, polyethylene glycol, itopride

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Jiao-Tong University School of Medicine Renji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

group PEG

group PEG+Itp

group PEG+4Itp

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2012
Last Updated
April 17, 2012
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01513811
Brief Title
Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective
Official Title
High Dose of Itopride: a Valid Adjuvant for Bowel Preparation in Patients With Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
bowel preparation, constipation, polyethylene glycol, itopride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group PEG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
group PEG+Itp
Arm Type
Active Comparator
Arm Description
Patients in group were assigned to itopride half hour before administration of lavage solution in the morning of examination day.
Arm Title
group PEG+4Itp
Arm Type
Active Comparator
Arm Description
Patients in this group received itopride three times 24 hours before the examination day and another time 30 min before administration of lavage solution.
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol electrolyte solutions
Other Intervention Name(s)
PEG-E
Intervention Description
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
Intervention Name(s)
Itopride and Polyethylene glycol electrolyte solutions
Other Intervention Name(s)
PEG-E, Itopride hydrochloride
Intervention Description
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
Intervention Name(s)
itopride and polyethylene glycol electrolyte solutions
Other Intervention Name(s)
PEG-E, itopride hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
the quality of bowel preparation
Description
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.
Time Frame
the day of colonoscopy examination
Secondary Outcome Measure Information:
Title
intestinal bubble scale
Description
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 Frame
the day of colonoscopy examination
Title
time of examination
Description
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.
Time Frame
the day of examination
Title
times of defecation
Description
The times of defecation during the preparation were obtained and analyzed.
Time Frame
the day before and the day of examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li X B, M.D., Ph.D.
Organizational Affiliation
Shanghai Jiao-Tong University School of Medicine Renji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Jiao-Tong University School of Medicine Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China

12. IPD Sharing Statement

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