In short
Clinical trials are investigating Sodium Picosulfate in bowel preparation before colonoscopy. These studies look at how well it cleans the bowel, how well people tolerate it, and whether it helps doctors get a better view during the exam. The trials include adults referred for colorectal cancer evaluation and children and teenagers with colonic disease.
Key points
- Clinical trials with Sodium Picosulfate are studying bowel cleansing before colonoscopy. The studies are in Phase 3 and compare it with other bowel preparation products. One trial includes adults referred to rule out colorectal cancer, and another includes children and teenagers with colonic disease. The main goals are to measure how well the bowel is cleaned, how well the preparation is tolerated, and whether colonoscopy findings are good enough for screening. One study also looks at adenoma detection rate, which shows how often at least one adenoma is found.
Trial overview
These clinical trials are studying Sodium Picosulfate as part of bowel preparation before colonoscopy. The studies focus on how well bowel cleansing works, how well people tolerate the preparation, and whether the colonoscopy exam quality is improved.
All three trials in the source data are interventional studies, which means the researchers give a planned treatment and then measure the results. Each listed trial is in Phase 3, a later stage of testing that usually compares treatments in larger groups of people.
Who is being studied
One trial includes people referred for colonoscopy to exclude colorectal cancer disease. 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.
Another trial includes patients undergoing colorectal cancer screening colonoscopy. Screening means the test is done to find disease early, sometimes before symptoms appear.
The third trial includes paediatric participants aged 1 to under 18 years with colonic disease. This is the only trial in the source data that clearly focuses on children and teenagers.
What the trials measure
The main outcome in one study is whether the efficacy of Plenvu is not inferior to Picoprep for bowel cleansing. In simple words, the trial asks whether Plenvu works at least as well as the comparison product within a set margin.
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. An adenoma is a bowel growth that can sometimes become cancer over time.
In the paediatric trial, the main outcome is the success rate of bowel cleansing, measured by the Boston Bowel Preparation Scale (BBPS). BBPS is a scoring system used to judge how clean the bowel is before the exam.
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.
Trial phases and study design
All three studies are Phase 3 trials. Phase 3 studies are usually designed to compare treatments in larger groups and confirm how well they work in real clinical use.
The first trial compares Plenvu with Picoprep as bowel cleansing agents before colonoscopy. 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.
The CLEAN+ trial is a randomized parallel comparative trial, which means people are placed into groups and followed side by side for comparison. It compares Clensia with Citrafleet and measures clinical efficacy through adenoma detection rate.
The paediatric study compares PLENVU with Sodium Picosulfate in children and teenagers before colonoscopy. The outcome is the rate of successful bowel cleansing based on BBPS.
Main trials included in this review
Trial 2024-518544-21-00 is an authorised Phase 3 study with 400 participants. It compares Plenvu and Picoprep as bowel cleansing agents before colonoscopy in people referred to exclude colorectal cancer disease. The study aims to see whether Plenvu is not inferior to Picoprep for efficacy and whether it may improve compliance and tolerability.
Trial 2025-523748-11-00 is an authorised Phase 3 study with 818 participants. It studies colorectal cancer early detection during screening colonoscopy and compares Clensia with Citrafleet in a randomized parallel design. The main endpoint is adenoma detection rate.
Trial 2025-522046-42-00 is an authorised Phase 3 study with 241 participants. It includes children and teenagers aged 1 to under 18 years with colonic disease and compares PLENVU with Sodium Picosulfate before colonoscopy. The main endpoint is successful bowel cleansing based on BBPS.
What these trials may mean for patients
For patients, these studies are mainly about making colonoscopy preparation more effective and easier to use. Better bowel cleansing can help the doctor see the bowel lining more clearly, which may improve the quality of the exam.
The trials do not study Sodium Picosulfate as a treatment for disease itself; they study its role in bowel preparation before examination. This is important because the main goal is better imaging and better test quality, not direct therapy.
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. The key question in each trial is whether the bowel preparation works well enough for a clear and useful colonoscopy.