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Recruiting NCT07231796

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

— Observational Cancer Opioid Induced Constipation (OIC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Naldemedine, an peripherally acting opioid antagonist.
Who it may be relevant to
Registry conditions: Cancer, Opioid Induced Constipation (OIC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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).

Primary outcome measures

  • The change in Bowel Function Index (BFI) score [Time frame: From enrollement to one week after initiation of naldemedine treatment]
Secondary outcome measures (7)
  • The change in Bowel Function Index (BFI) score [Time frame: From enrollment to two weeks after initiation of naldemedine]
  • A clinically meaningful improvement in constipation [Time frame: 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 [Time frame: From enrollment to two weeks of treatment]
  • The change in Patient Assessment of Constipation, Quality of Life (PAC-QoL) scores [Time frame: From enrollment to two weeks of treatment with naldemedine]
  • Continuation of naldemedine [Time frame: From enrollment to two weeks after initiation of naldemedine]
  • Patient Satisfaction [Time frame: From enrollment to two weeks of treatment with naldemedine]
  • Patient likelihood to recommend the use of naldemedine to other patients [Time frame: From enrollment to two weeks of treatment with naldemedine]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Amsterdam UMC — Amsterdam

Identifiers

NCT: NCT07231796 · 2025.0837

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗