DRUG
2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.
Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
Status
Unknown
Phase
Phase 4
Enrollment
600
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
Full detailed description
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation. Prucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.
Interventions
Treatment arms and agents.
DRUG
2 mg Placebo plus 2 L Polyethylene Glycol regimen
Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.
Timeline
From registration to results.
First posted
May 24, 2016
Study start
Jun 2016
Primary completion
Mar 2017
Study completion
Mar 2017
Results posted
Not reported
Registry updated
May 27, 2016
Outcomes
What the study measures.
Primary outcomes
Difference of scores rating by Boston Bowel Preparation Scale between 2 groups.
Time frame · 9 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between 2 groups.
Secondary outcomes
Polyp detection rate between 2 groups.
Time frame · 9 months
rate of adverse events between 2 groups.
Time frame · 9 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Patients 18 years of age or older, * scheduled to undergo elective outpatient colonoscopy, * and were able to provide informed consent. Exclusion Criteria: * history of colorectal surgery * severe colonic stricture or obstructing tumour * dysphagia * compromised swallowing reflex or mental status * significant gastroparesis or gastric outlet obstruction * known or suspected bowel obstruction or perforation * severe chronic renal failure (creatinine clearance\<30 ml/min * severe congestive heart failure (New York Heart Association class III or IV) * uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg) * dehydration * disturbance of electrolytes * pregnancy or lactation * haemodynamically unstable * unable to give informed consent.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.