2024-518544-21-00
Recruiting
Phase 4
A Randomised controlled trial to compare efficacy and tolerability of Plenvu® and Picoprep® as cleansing agents before colonoscopy
Aalborg University Hospital1 site in 1 country400 target enrollmentStarted: November 5, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Aalborg University Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Efficacy of plenvu is not inferior to picoprep
Overview
Brief Summary
Aim of the study is to compare the efficacy and tolerability of the relatively new bowel preparation Plenvu® with the well established bowel preparation Picoprep® as cleansing agents before colonoscopy. This is to test whether the low volume Polyethylin Glycol-electrolytes lavage solution preparation Plenvu® would have non-inferior efficacy on bowel preparation compared with Picosulfate based Picoprep® with a better effect on compliance and tolerability.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ambulant colonoscopy
- •Older than18
Exclusion Criteria
- •Younger than 18
- •Patients with Phenylketonuria
- •Patients with Glucose-6-phosphate-dehydrogenase deficiency
- •Patients with rectum and/or colon resections
- •Known with severe heart failure
- •Known with severe renal failure (eGFR<30)*
- •Known with colonic stenosis
- •Pregnant or breastfeeding
- •Acute colonoscopy
- •Cancer screening program colonoscopy
Outcomes
Primary Outcomes
Efficacy of plenvu is not inferior to picoprep
Efficacy of plenvu is not inferior to picoprep
Secondary Outcomes
- Tolerability of plenvu is not inferior to picoprep
Investigators
Hayder Alqaisi
Scientific
Aalborg University Hospital
Study Sites (1)
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