Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A phase III, international, multiCenter, randomized, paraLlel-group, Endoscopist-blinded non-inferiority study of the efficAcy, safety and patient acceptance of mannitol veRsus Plenvu® in boWel prepAration for elective colonoscopY. CLEARWAY

The CLEARWAY study is a research project looking at two different high-strength laxatives, Mannitol and Plenvu, that people take to clean out their bowels before a colonoscopy. A colonoscopy is a procedure where a doctor looks inside your large bowel. The main goal is to find out if Mannitol works just as well as Plenvu in thoroughly cleaning the bowel, which is very important for the doctor to get a clear view. Researchers are also looking at how safe each preparation is, how easy they are to take, and what patients think of the taste. The study includes adult patients who are scheduled to have an elective colonoscopy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Ntc S.r.l.

Enrolment target

520

Start

16 Jul 2025

Subjects scheduled for elective colonoscopy performed according to ESGE (European Society of Gastrointestinal Endoscopy) guidelines.

What is this study about?

When you need to have a colonoscopy, it's really important that your bowel is as clean as possible. This allows the doctor performing the procedure to see everything clearly and properly check for any problems, like polyps. To achieve this, you'll need to take a special medication called a bowel preparation, which helps to clear out your digestive system.

This study, called CLEARWAY, is comparing two different bowel preparations: Mannitol and a product called Plenvu. Both are commonly used for this purpose. The main aim is to see if Mannitol is as effective as Plenvu at cleaning the bowel. Essentially, we want to know if Mannitol does just as good a job, which could offer another good option for patients.

Beyond just how well they clean, the researchers are also very interested in how safe these preparations are for patients. They will be carefully monitoring for any side effects. Crucially, they also want to understand the patient experience – how easy each preparation is to take, what it tastes like, and whether patients would be happy to use it again. This helps healthcare providers offer the best and most comfortable options for patients preparing for a colonoscopy.

Key takeaways

Compares Mannitol and Plenvu for colonoscopy preparation.
Aims to see if Mannitol is as effective and safe as Plenvu.
Investigates patient experience, including taste and ease of use.
Participation requires a scheduled colonoscopy.
Your health and comfort will be monitored closely throughout the study.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women can take part. To be considered, you must have a colonoscopy already scheduled with your doctor. This colonoscopy must be a planned one, not an emergency.

You should also be generally fit and well enough to undergo a colonoscopy safely, as decided by your doctors. The study will confirm if you meet all the specific health requirements for participation.

There might be some specific health conditions or medications that would prevent you from taking part, even if you are having a colonoscopy. This is to ensure your safety throughout the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for a planned (non-emergency) colonoscopy?
Are you comfortable with the possibility of taking either Mannitol or Plenvu?
Are you generally in good health and able to complete the study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the CLEARWAY study, you'll be given either Mannitol or Plenvu to take before your colonoscopy. Neither you nor the doctor performing the colonoscopy will know which preparation you've received, to keep the results fair.

Before your colonoscopy, you'll be asked to take the bowel preparation as instructed. The study team will check on you during this time and ask about any side effects. After your colonoscopy, the doctor will give a score on how clean your bowel was. You'll also be asked about your experience, including how easy the preparation was to take, its taste, and if you would use it again. There will be some blood tests before and after taking the preparation, and you'll have follow-up visits or calls to check on your health and any long-term effects. The total duration of your active involvement in the study will be relatively short, focused around your colonoscopy procedure and immediate follow-up.

Potential risks and benefits

Taking part in this study may offer some benefits, such as contributing valuable information that could help future patients undergoing colonoscopies. You will receive either a standard bowel preparation or another similar preparation, both aimed at effectively cleaning your bowel for your colonoscopy. However, all medical treatments carry potential risks. Bowel preparations can cause side effects like nausea, vomiting, stomach cramps, and dehydration. The study team will closely monitor you and ensure you receive appropriate medical care if any side effects occur. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Spain
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Unverified
Sweden
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Unverified
Poland
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Unverified
Italy

Common questions

What is a colonoscopy?

A colonoscopy is a medical procedure where a doctor uses a thin, flexible tube with a camera to look inside your large bowel (colon) and rectum to check for any problems.

Why do I need to take a bowel preparation?

It's essential to clean out your bowel completely before a colonoscopy so the doctor can get a clear view of the lining and spot any issues that might be there.

What will I be taking in this study?

You will be given either Mannitol or Plenvu, which are both types of medication used to clean your bowel before a colonoscopy. They are both strong laxatives.

Will I know which medication I'm taking?

Neither you nor the doctor performing your colonoscopy will know whether you are taking Mannitol or Plenvu. This is to keep the study fair and unbiased.

Are there any side effects?

Bowel preparations can cause side effects like feeling sick, vomiting, stomach cramps, and dehydration. The study team will monitor you for any reactions.