Europas førende søgning efter kliniske forsøg

Sodium Picosulfate

Clinical trials with Sodium Picosulfate are studying bowel cleansing before colonoscopy. The trials compare how well it works against other bowel preparation products and how well patients tolerate the preparation. The target groups include adults referred for colorectal cancer checks and children and teenagers with colonic disease.

Table of contents

Trial overview

The available trials study Sodium Picosulfate as part of bowel preparation before colonoscopy.[1][3] The research is not about treating the bowel disease itself, but about making the bowel clean enough so the doctor can see the bowel lining well during the examination.[1]

All three listed studies are Phase 3 interventional trials, which means participants receive one of the study preparations and the results are compared in larger groups.[1][2][3]

Adult colonoscopy studies

One adult trial compares Plenvu® with Picoprep® as bowel cleansing agents before colonoscopy in patients referred to exclude colorectal cancer.[1] The study asks whether Plenvu® is not inferior to Picoprep® for bowel cleansing, and it also looks at tolerability, which means how well patients can take the preparation.[1]

Another adult study, called CLEAN+, compares Clensia® with CitraFleet® in people having screening colonoscopy for early detection of colorectal cancer.[2] The main outcome is the adenoma detection rate, which is the proportion of patients in whom at least one adenoma is found.[2]

In the trial data, CitraFleet® is the preparation linked to Sodium Picosulfate, so this study is relevant to research on this substance.[2]

Pediatric study

The pediatric trial studies children and teenagers aged 1 to under 18 years with colonic disease who are preparing for colonoscopy.[3] It compares PLENVU® with Sodium Picosulfate and measures how many participants achieve adequate bowel cleansing.[3]

This study uses the Boston Bowel Preparation Scale, often shortened to BBPS, to judge whether cleansing is successful.[3] In simple terms, BBPS is a scoring system that shows how clean the bowel is before the camera examination.[3]

Main outcomes and endpoints

The adult trial with Plenvu® and Picoprep® has a primary outcome of non-inferiority, meaning the researchers want to know whether Plenvu® works at least as well as Picoprep® for bowel cleansing.[1] The same study also looks at tolerability, which is how acceptable the preparation is for patients.[1]

The CLEAN+ study measures the adenoma detection rate, which is important because finding adenomas during screening can help identify patients who need further care.[2]

The pediatric study measures the success rate of bowel cleansing, defined as the percentage of participants with adequate cleansing on BBPS.[3]

Study design and phases

All three trials are interventional, so the study team gives participants one of the bowel preparation products and then compares the results.[1][2][3]

Each trial is in Phase 3, which usually means the preparation has already been studied earlier and is now being compared in more people to confirm how well it works in practice.[1][2][3]

The planned enrollment is 400 participants in the adult Plenvu® versus Picoprep® study, 818 participants in CLEAN+, and 241 participants in the pediatric study.[1][2][3]

Who can participate

The adult Plenvu® versus Picoprep® trial includes patients referred for colonoscopy to exclude colorectal cancer.[1] The CLEAN+ study includes people having colorectal cancer screening colonoscopy.[2]

The pediatric study includes children and teenagers with colonic disease who are scheduled for colonoscopy and are aged 1 to under 18 years.[3] The trial data do not give full inclusion or exclusion rules, so participation depends on each study’s own screening process.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2024-518544-21-00 Phase 3 Bowel cleansing before colonoscopy in patients referred to exclude colorectal cancer Authorised 400
2025-523748-11-00 Phase 3 Colorectal cancer early detection during screening colonoscopy Authorised 818
2025-522046-42-00 Phase 3 Colonic disease in children and teenagers before colonoscopy Authorised 241

FAQ

  • What are the clinical trials with Sodium Picosulfate studying? They are studying bowel cleansing before colonoscopy. The main goals are to see how well the bowel is cleaned and how well patients tolerate the preparation.
  • Who can take part in these trials? The trial data include adults referred for colonoscopy to exclude colorectal cancer and children and teenagers aged 1 to under 18 years with colonic disease. Each trial has its own rules for who can join.
  • What phase are the Sodium Picosulfate trials in? The listed trials are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups of people to compare results and measure how well it works.
  • What outcomes are being measured? The trials measure bowel cleansing success, non-inferiority, tolerability, and in one screening study the adenoma detection rate. BBPS, or Boston Bowel Preparation Scale, is used in the pediatric study to judge cleansing quality.
  • What conditions are being studied in these trials? The trials focus on bowel preparation before colonoscopy for colorectal cancer assessment, early detection of colorectal cancer, and colonic disease in children and teenagers.

Igangværende kliniske forsøg for Sodium Picosulfate

  • Undersøgelse af effekten af en kombination af simeticon og en lægemiddelkombination bestående af natriumpikosulfat, magnesiumoxid og citronsyre til forberedelse af screening for tyktarmskræft.

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Spanien

  • Undersøgelse af tarmrensning med macrogol 3350 kombineret med andre stoffer sammenlignet med natriumpicosulfat hos børn og unge før koloskopi

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Belgien Tyskland Ungarn Italien Holland Polen +2

  • Sammenligning af Plenvu® og Picoprep® til tarmrensning før kikkertundersøgelse af tyktarmen ved mistanke om tarmkræft

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Danmark

Ordliste

  • Colonoscopy: An examination of the large bowel using a flexible camera tube. It helps doctors look inside the bowel and find changes such as polyps or cancer.
  • Bowel cleansing: The process of emptying and cleaning the bowel before colonoscopy so the doctor can see the bowel lining clearly.
  • Colorectal cancer: Cancer that starts in the colon or rectum. Some trials include people referred for checks to rule this out.
  • Early detection: Finding a disease at an early stage, before it causes serious problems. One trial studies screening colonoscopy for early detection of colorectal cancer.
  • Phase 3: A later stage of clinical research where a treatment is tested in larger groups to compare how well it works and how well it is tolerated.
  • Interventional study: A study where participants receive one of the tested preparations so researchers can compare outcomes.
  • Tolerability: How well patients are able to take and complete a preparation, including whether it is acceptable and easy to use.
  • Non-inferior: A result showing that one treatment is not worse than another by more than a set amount.
  • Adenoma: A growth in the bowel that is not cancer, but can be important because it may be found and removed during screening.
  • Boston Bowel Preparation Scale (BBPS): A scoring system used to judge how clean the bowel is after preparation before colonoscopy.

Referencer

  1. https://clinicaltrials.gov/study/2024-518544-21-00
  2. https://clinicaltrials.gov/study/2025-523748-11-00
  3. https://clinicaltrials.gov/study/2025-522046-42-00