ConstipationPhase 2NCT01513811
Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective
A Phase 2 study testing Polyethylene glycol electrolyte solutions and Itopride and Polyethylene glycol electrolyte solutions in people with Constipation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- Polyethylene glycol electrolyte solutions and Itopride and Polyethylene glycol electrolyte solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao-Tong University School of Medicine Renji Hospital
Shanghai, Shanghai Municipality, 200001
About this study
Official title: High Dose of Itopride: a Valid Adjuvant for Bowel Preparation in Patients With Chronic Constipation
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.
Read the 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
- Being tested
- Polyethylene glycol electrolyte solutions, Itopride and Polyethylene glycol electrolyte solutions
- Keywords
- bowel preparation, constipation, polyethylene glycol, itopride
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol electrolyte solutionsDrug
Also called PEG-E
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 solutionsDrug
Also called PEG-E, Itopride hydrochloride
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 solutionsDrug
Also called PEG-E, itopride hydrochloride
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: itopride and polyethylene glycol electrolyte solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the day of colonoscopy examination
Secondary outcomes (3)
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.
Measured: the day of colonoscopy examination
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.
Measured: the day of examination
times of defecation
The times of defecation during the preparation were obtained and analyzed.
Measured: the day before and the day of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startFeb 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Li X B, M.D., Ph.D., Study chair, Shanghai Jiao-Tong University School of Medicine Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513811
- Sponsor's protocol ID
- rjyyxhk0906
- Status last verified
- Apr 2012
- First submitted
- 16 Jan 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose of Itopride: a Valid Adjuvant for Bowel Preparation in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT01513811
- Acronym / sponsor ID
- rjyyxhk0906
- Conditions
- Constipation
- Keywords
- bowel preparation, constipation, polyethylene glycol, itopride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group PEG | Active comparator | Drug: Polyethylene glycol electrolyte solutionsThis 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 PEG+Itp | Active comparator | Drug: Itopride and Polyethylene glycol electrolyte solutionsPatients in group were assigned to itopride half hour before administration of lavage solution in the morning of examination day. |
| group PEG+4Itp | Active comparator | Drug: itopride and polyethylene glycol electrolyte solutionsPatients in this group received itopride three times 24 hours before the examination day and another time 30 min before administration of lavage solution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene glycol electrolyte solutionsAlso: PEG-EPatients 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. | Drug | group PEG |
| Itopride and Polyethylene glycol electrolyte solutionsAlso: PEG-E, Itopride hydrochloridePatients 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. | Drug | group PEG+Itp |
| itopride and polyethylene glycol electrolyte solutionsAlso: PEG-E, itopride hydrochloridePatients 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. | Drug | group PEG+4Itp |
Primary outcome
the quality of bowel preparation
Time frame: the day of colonoscopy examination
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.
3 secondary outcomes
intestinal bubble scale
Time frame: the day of colonoscopy examination
time of examination
Time frame: the day of examination
times of defecation
Time frame: the day before and the day of examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li X B, M.D., Ph.D. study chair
Shanghai Jiao-Tong University School of Medicine Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polyethylene glycol electrolyte solutions and Itopride and Polyethylene glycol electrolyte solutions in people with Constipation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the quality of bowel preparation (time frame: the day of colonoscopy examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.