Table of contents

• Trial overview
• Who is being studied
• What the trials measure
• Trial phases and study design
• Main trials included in this review
• What these trials may mean for patients

Trial overview

These clinical trials are studying Sodium Picosulfate as part of bowel preparation before colonoscopy.^[1] The studies focus on how well bowel cleansing works, how well people tolerate the preparation, and whether the colonoscopy exam quality is improved.^[1]

All three trials in the source data are interventional studies, which means the researchers give a planned treatment and then measure the results.^{[1][2][3] Each listed trial is in Phase 3, a later stage of testing that usually compares treatments in larger groups of people.[1][2][3]}

Who is being studied

One trial includes people referred for colonoscopy to exclude colorectal cancer disease.^[1] This means the bowel cleansing is being tested in people who need the colon exam for a cancer check, not as a direct cancer treatment.^[1]

Another trial includes patients undergoing colorectal cancer screening colonoscopy.^[2] Screening means the test is done to find disease early, sometimes before symptoms appear.^[2]

The third trial includes paediatric participants aged 1 to under 18 years with colonic disease.^[3] This is the only trial in the source data that clearly focuses on children and teenagers.^[3]

What the trials measure

The main outcome in one study is whether the efficacy of Plenvu is not inferior to Picoprep for bowel cleansing.^[1] In simple words, the trial asks whether Plenvu works at least as well as the comparison product within a set margin.^[1]

In the CLEAN+ trial, the main outcome is adenoma detection rate, which is the proportion of patients with at least one adenoma found during colonoscopy.^[2] An adenoma is a bowel growth that can sometimes become cancer over time.^[2]

In the paediatric trial, the main outcome is the success rate of bowel cleansing, measured by the Boston Bowel Preparation Scale (BBPS).^[3] BBPS is a scoring system used to judge how clean the bowel is before the exam.^[3]

Tolerability is also an important focus in the adult bowel preparation trial, meaning the researchers want to know how acceptable the preparation is for patients.^[1]

Trial phases and study design

All three studies are Phase 3 trials.^{[1][2][3] Phase 3 studies are usually designed to compare treatments in larger groups and confirm how well they work in real clinical use.[1][2][3]}

The first trial compares Plenvu with Picoprep as bowel cleansing agents before colonoscopy.^[1] The source text says the goal is to test whether Plenvu has non-inferior efficacy and better compliance and tolerability than the picosulfate-based comparator.^[1]

The CLEAN+ trial is a randomized parallel comparative trial, which means people are placed into groups and followed side by side for comparison.^[2] It compares Clensia with Citrafleet and measures clinical efficacy through adenoma detection rate.^[2]

The paediatric study compares PLENVU with Sodium Picosulfate in children and teenagers before colonoscopy.^[3] The outcome is the rate of successful bowel cleansing based on BBPS.^[3]

Main trials included in this review

Trial 2024-518544-21-00 is an authorised Phase 3 study with 400 participants.^[1] It compares Plenvu and Picoprep as bowel cleansing agents before colonoscopy in people referred to exclude colorectal cancer disease.^[1] The study aims to see whether Plenvu is not inferior to Picoprep for efficacy and whether it may improve compliance and tolerability.^[1]

Trial 2025-523748-11-00 is an authorised Phase 3 study with 818 participants.^[2] It studies colorectal cancer early detection during screening colonoscopy and compares Clensia with Citrafleet in a randomized parallel design.^[2] The main endpoint is adenoma detection rate.^[2]

Trial 2025-522046-42-00 is an authorised Phase 3 study with 241 participants.^[3] It includes children and teenagers aged 1 to under 18 years with colonic disease and compares PLENVU with Sodium Picosulfate before colonoscopy.^[3] The main endpoint is successful bowel cleansing based on BBPS.^[3]

What these trials may mean for patients

For patients, these studies are mainly about making colonoscopy preparation more effective and easier to use.^{[1][2][3] Better bowel cleansing can help the doctor see the bowel lining more clearly, which may improve the quality of the exam.[1]}

The trials do not study Sodium Picosulfate as a treatment for disease itself; they study its role in bowel preparation before examination.^{[1][3] This is important because the main goal is better imaging and better test quality, not direct therapy.[1][3]}

Because the studies include both adults and younger patients, the source data suggests that Sodium Picosulfate is being studied across different age groups and clinical settings.^{[1][3] The key question in each trial is whether the bowel preparation works well enough for a clear and useful colonoscopy.[1][2][3]}