Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp

Treatments: Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen; Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT02781493

2016SDU-QILU-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups, including a placebo group

Prucalopride group

Experimental group

Description:

2 mg Prucalopride plus 2 L Polyethylene Glycol regimen

Treatment:

Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen

Placebo group

Placebo Comparator group

Description:

2 mg Placebo plus 2 L Polyethylene Glycol regimen

Treatment:

Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen