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Macrogol 4000

Clinical trials of Macrogol 4000 are studying how well it works in different patient groups, including people scheduled for colonoscopy and patients with hip fracture after surgery. These studies look at outcomes such as bowel cleansing, need for rescue laxatives, and how patients tolerate the treatment. They also compare Macrogol 4000 with other bowel preparation or laxative options.

Table of Contents

Overview of the trials

The trial data show that Macrogol 4000 is being studied in patient groups where bowel cleansing or bowel function is important.[1][2] The main research areas are elective colonoscopy, constipation prevention after hip surgery, and colorectal cancer screening colonoscopy.[1][2][3]

Most of the listed studies are Phase 3 trials, while some are Phase 2 trials in other clinical settings.[1][2][3][4][5] This means the research is focused on comparing treatments in larger groups and checking outcomes that matter to patients and doctors.[1][2]

Bowel preparation for colonoscopy

One completed Phase 3 study, CLEARWAY, looked at adults scheduled for elective colonoscopy performed according to ESGE guidelines.[1] It compared mannitol with Plenvu®, which contains MACROGOL, COMBINATIONS in the intervention list, and studied whether the bowel was cleaned well enough for the procedure.[1]

The primary endpoint was the proportion of patients with adequate bowel cleansing, defined by the BBPS total score and segment scores in the right, transverse, and left colon.[1] In simple terms, the study checked how clean each part of the bowel was so the endoscopist could see clearly during colonoscopy.[1]

Another Phase 3 study, CLEAN+, focused on colorectal cancer early detection colonoscopy.[3] It compared two bowel preparation products, Clensia® and Citrafleet®, and measured the adenoma detection rate, which is the share of patients in whom at least one adenoma was found.[3]

Although CLEAN+ does not list Macrogol 4000 by name in the intervention field, it belongs to the same broad area of bowel preparation research and shows how these trials focus on the quality of colonoscopy screening.[3]

Constipation prevention after hip surgery

The trial titled “What laxatives after hip surgery?” is a Phase 3 study in patients with hip fracture.[2] It compares MACROGOL, COMBINATIONS with bisacodyl to find the best way to prevent constipation after surgery.[2]

The main endpoint is the proportion of patients who need rescue medication after 72 hours or before 72 hours based on medical assessment.[2] This endpoint shows whether the first laxative plan was enough or whether extra treatment was needed.[2]

This study is important because it looks at a common problem after hip surgery: constipation, which can cause discomfort and slow recovery.[2] The trial is designed to compare treatment options in a real patient group after surgery.[2]

Other studies in the trial data

The trial data also include a Phase 2 study in intensive care patients who were intoxicated by toxic substances and were intubated.[4] That study used digestive decontamination treatments and measured the change in plasma toxic substance levels at 24 hours.[4]

Another Phase 2 study, RESCUE-HUB, involved patients with unresectable hepatocellular carcinoma and tested fecal microbiota transplantation added to atezolizumab plus bevacizumab after early progression.[5] Its endpoints included safety, measured by severe adverse events, and efficacy, measured by disease control rate at 12 weeks.[5]

These studies are part of the same source set, but they do not directly study Macrogol 4000 as the main intervention in the way the colonoscopy and hip surgery trials do.[4][5]

Main endpoints and how results are measured

Across the trial data, the main endpoints are practical measures that show whether the treatment worked.[1][2][3] For colonoscopy studies, the focus is on bowel cleanliness and adenoma detection.[1][3]

For the hip surgery study, the key measure is whether patients needed rescue medication after the planned laxative treatment.[2] In the cancer and intensive care studies, the endpoints are disease control, safety, or changes in toxic substance levels.[4][5]

These endpoints are useful because they show not just whether a treatment was given, but whether it helped in a clear and measurable way.[1][2]

Study design, phases, and who can join

The listed studies are interventional, which means researchers assign treatments and then compare outcomes between groups.[1][2][3][4][5] The colonoscopy study CLEARWAY is randomized, parallel-group, and endoscopist-blinded, which helps make the comparison fair and reduces bias.[1]

The target populations are clearly defined in each trial: adults scheduled for elective colonoscopy, patients with hip fracture after surgery, intensive care patients with toxic ingestion, and patients with unresectable hepatocellular carcinoma.[1][2][4][5] Enrollment ranges from small studies with 15 participants to larger studies with more than 800 participants.[1][3][5]

Overall, the trial data show that Macrogol 4000 is being explored mostly in settings where bowel preparation or bowel regularity matters, with outcomes chosen to reflect real clinical needs.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2025-521451-23-00Phase 3Elective colonoscopy bowel preparationCompleted520
2024-513871-42-00Phase 3Hip fracture after surgery, constipation preventionAuthorised375
2025-523748-11-00Phase 3Colorectal cancer early detection colonoscopyAuthorised818
2024-518739-12-00Phase 2Intensive care patients with toxic substance ingestionAuthorised200
2023-510504-45-00Phase 2Unresectable hepatocellular carcinomaAuthorised15

FAQ

  • What are clinical trials of Macrogol 4000 trying to find out? The trials are mainly checking how effective Macrogol 4000 is in bowel preparation and constipation prevention. They also measure patient acceptance and other outcomes such as the need for rescue medication.
  • Who can take part in these trials? The target groups include adults scheduled for elective colonoscopy and patients with hip fracture after surgery. One trial also studied patients in intensive care, but that study used other treatments alongside bowel cleansing.
  • What phase are the Macrogol 4000 trials? The available trials are mainly Phase 3 studies, with some Phase 2 studies in other clinical settings. This means the research is focused on testing effectiveness and safety in larger patient groups.
  • What conditions are being studied with Macrogol 4000? The main conditions are bowel preparation for colonoscopy and prevention of constipation after hip surgery. The trial data also include studies in colorectal cancer screening settings where bowel cleansing is important.
  • How do researchers measure success in these trials? They use endpoints such as adequate bowel cleansing, adenoma detection rate, and the proportion of patients needing rescue medication. Some studies also measure safety and patient tolerance.

Ongoing Clinical Trials on Macrogol 4000

  • Study on Preventing Constipation After Hip Fracture Surgery Using Bisacodyl and a Drug Combination for Post-Surgery Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • A study comparing the effectiveness of a simeticone drug combination and a sodium picosulfate drug combination for bowel preparation in patients undergoing colorectal cancer screening.

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Fecal Microbiota Transplantation combined with atezolizumab and bevacizumab in patients with unresectable liver cancer who progressed after initial treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Reduction of Toxicant Levels in Blood through Combined Digestive Decontamination with Activated Charcoal and Intestinal Purge for Intubated Patients with Major Poisoning in Intensive Care

    Not yet recruiting

    1 1 1
    Investigated drugs:
    France

  • Efficacy and Safety of Mannitol Compared to Plenvu for Bowel Preparation in Patients Undergoing Elective Colonoscopy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Poland Spain Sweden

Glossary

  • Clinical trial: A research study in people that tests whether a treatment works and is safe.
  • Phase 2: An earlier stage of testing that looks more closely at safety and whether a treatment seems to work.
  • Phase 3: A later stage of testing in larger groups of people to compare treatments and confirm results.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Randomized: Participants are assigned to treatment groups by chance, which helps make the comparison fair.
  • Parallel-group: A study design where different groups receive different treatments at the same time.
  • Endoscopist-blinded: The doctor doing the endoscopy does not know which treatment the patient received, which helps reduce bias.
  • Bowel cleansing: Cleaning the bowel before a colonoscopy so the doctor can see the inside of the colon clearly.
  • BBPS: Short for Boston Bowel Preparation Scale, a score used to judge how clean the bowel is before or during colonoscopy.
  • Adenoma detection rate: The percentage of patients in whom at least one adenoma, a non-cancerous growth, is found during colonoscopy.
  • Rescue medication: An extra treatment given if the first treatment does not work well enough.
  • RECIST 1.1: A standard way to measure how cancer responds to treatment by checking if it shrinks, stays the same, or grows.

References

  1. https://clinicaltrials.gov/study/2025-521451-23-00
  2. https://clinicaltrials.gov/study/2024-513871-42-00
  3. https://clinicaltrials.gov/study/2025-523748-11-00
  4. https://clinicaltrials.gov/study/2024-518739-12-00
  5. https://clinicaltrials.gov/study/2023-510504-45-00