Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProfessor Monique A. H. Steegers

About this trial

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.

Eligibility criteria

Qualifiers

Adult (≥18 years)

A diagnosis of malignancy

Daily use of opioids

Use of laxatives

Disqualifiers

Use of other opioid antagonists in the last month

Suspected (risk of) gastrointestinal perforation

Participation in another study that may confound the results of this trial

Trial design

Treatments tested in this trial

  • Naldemedine, an peripherally acting opioid antagonist

Treatment groups

No treatment groups listed

Sponsors and collaborators

Professor Monique A. H. Steegers

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution

Viatris Inc.

Collaborator