Actively Recruiting
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Led by Professor Monique A. H. Steegers · Updated on 2026-01-02
100
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
Sponsors
P
Professor Monique A. H. Steegers
Lead Sponsor
V
Viatris Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study looks at how well a medicine called naldemedine works for people with cancer who become constipated while taking opioids. Opioids are medications prescribed to treat persistent or severe pain. Opioids can slow down the bowel and make it hard to pass stool. About 6 out of 10 people who use opioids have constipation. Laxatives such as lactulose or macrogol are described to help with this problem. If laxatives do not work, doctors may use special medicines called opioid blockers that act only in the gut. These medicines help relieve constipation without reducing pain relief. Naldemedine is one of these opioid blockers. It became available in the Netherlands in 2024 but is not yet widely used. The goal of this study is to learn how well naldemedine works in everyday care and how people feel while using it. Researchers will collect information on both medical results and participants' experiences.
CONDITIONS
Official Title
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (≥18 years)
- Diagnosis of malignancy (cancer)
- Daily use of opioid medications
- Current use of laxatives
- Experiencing constipation with a Bowel Function Index (BFI) score of 30 or higher
- Ability to complete Dutch-language questionnaires
- Ability to provide written informed consent
You will not qualify if you...
- Use of other opioid antagonists within the last month
- Suspected or risk of gastrointestinal perforation
- Participation in another study that could affect this trial's results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
J
Josje Evers, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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