2024-518544-21-00RecruitingPhase 4
A trial to compare efficacy and tolerability of Plenvu® and Picoprep® as cleansing agents of the large bowel before colonoscopy (examination of the bowel with a fiberoptic device)
A Randomised controlled trial to compare efficacy and tolerability of Plenvu® and Picoprep® as cleansing agents before colonoscopy
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 15 Oct 2024
- Start date
- 1 Sept 2022
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Colorectal cancer
- EU CT number
- 2024-518544-21-00
- EudraCT number
- 2021-006617-11
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are having an outpatient colonoscopy. It compares two bowel cleansing products, Plenvu and Picoprep, taken before the exam.
- Age
- Older than 18 (minimum age 18 years)
- Sex
- All sexes can join
- Earlier treatment
- People who had a colonoscopy in this study that was cancelled because of bad bowel preparation cannot join again.
Main reasons for not taking part
- Phenylketonuria
- Glucose-6-phosphate-dehydrogenase deficiency
- Earlier surgery removing part of the rectum or colon
- Known severe heart failure or severe kidney failure (eGFR<30)
- Pregnant or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known with severe heart failure
- Cancer screening program colonoscopy
Lab values
- Patients with Glucose-6-phosphate-dehydrogenase deficiency
- Known with severe renal failure (eGFR<30)*
Age
- Younger than 18
Other
- Patients with Phenylketonuria
- Patients with rectum and/or colon resections
- Known with colonic stenosis
- Pregnant or breastfeeding
- Acute colonoscopy
- Mentally retarded
- Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.
Who the study is looking for
- Ambulant colonoscopy
- Older than18
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.