Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

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Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

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Detailed Description

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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.

Conditions

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Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Prucalopride group

2 mg Prucalopride plus 2 L Polyethylene Glycol regimen

Group Type EXPERIMENTAL

2 mg Prucalopride plus 2 L Polyethylene Glycol regimen

Intervention Type DRUG

Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.

Placebo group

2 mg Placebo plus 2 L Polyethylene Glycol regimen

Group Type PLACEBO_COMPARATOR

2 mg Placebo plus 2 L Polyethylene Glycol regimen

Intervention Type DRUG

Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No