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

NCT07231796 | Recruiting

• 1 other identifier: 2025.0837
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• The change in Bowel Function Index (BFI) score

  Bowel Function Index (BFI) is a brief, three-item questionnaire assessing opioid-induced constipation over the past 7 days. It measures ease of defecation, sensation of incomplete evacuation and personal judgment of constipation, each rated on a 0-100 numerical rating scale. Scores are averaged and recalculated to a 0-100 scale; a score ≥30 indicates clinically significant opioid-induced constipation.

  From enrollement to one week after initiation of naldemedine treatment

Secondary Outcomes (7)

• The change in Bowel Function Index (BFI) score

  From enrollment to two weeks after initiation of naldemedine

• A clinically meaningful improvement in constipation

  From baseline to one week after treatment initiation and from baseline to two weeks after treatment initiation.

• The prevalence of persistent constipation, defined as a BFI score ≥ 30

  From enrollment to two weeks of treatment

• The change in Patient Assessment of Constipation, Quality of Life (PAC-QoL) scores

  From enrollment to two weeks of treatment with naldemedine

• Continuation of naldemedine

  From enrollment to two weeks after initiation of naldemedine

Interventions

Naldemedine, an peripherally acting opioid antagonist DRUG

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adults with cancer who are treated with opioids for pain managment. They will be recruited from multiple hospitals in the Netherlands. All participants will already be using laxatives to manage constipation. People who take part must be able to read Dutch and give written consent. Participants will represent a real-world group of individuals using opioids for cancer-related pain in daily clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Monique A. H. Steegers: lead
• Viatris Inc.: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasms; Opioid-Induced Constipation

Interventions

naldemedine

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Josje Evers, MD

CONTACT

+31650087799; j.evers@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof dr.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-11

Locations

NL (1)