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

NCT ID: NCT07231796

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2027-03-15

Brief 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.

Conditions

Cancer; Opioid Induced Constipation (OIC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Naldemedine, an peripherally acting opioid antagonist

Participants will be treated with naldemedine 0.2 milligrams orally once daily as monotherapy for a duration of 14 consecutive days, following discontinuation of laxatives, as intervention for opioid-induced constipation (OIC).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viatris Inc.

INDUSTRY

Sponsor Role: collaborator

Professor Monique A. H. Steegers

OTHER

Sponsor Role: lead

Responsible Party

Professor Monique A. H. Steegers

Prof dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Amsterdam UMC

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Josje Evers, MD

Role: CONTACT

j.evers@amsterdamumc.nl

+31650087799

Facility Contacts

Josje Evers, MD

Role: primary

j.evers@amsterdamumc.nl

+31650087799

Other Identifiers

2025.0837

Identifier Type: -

Identifier Source: org_study_id