Opioid Induced Constipation Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult (≥18 years)

• A diagnosis of malignancy

• Daily use of opioids

• Use of laxatives

• Experiencing constipation, defined as a Bowel Function Index (BFI) score ≥30

• Able to complete a Dutch-language questionnaire

• Able to provide written informed consent

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Josje Evers, MD
j.evers@amsterdamumc.nl
+31650087799
Time Frame
Start Date: 2026-01-02
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Collaborators: Viatris Inc.
Leads: Professor Monique A. H. Steegers

This content was sourced from clinicaltrials.gov

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