Clinical trial · Observational
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced Constipation: Clinical Outcomes and Patient Experience
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Opioid Induced Constipation (OIC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Naldemedine, an peripherally acting opioid antagonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The change in Bowel Function Index (BFI) score
- timeFrame
- From enrollement to one week after initiation of naldemedine treatment
- description
- 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.
Secondary outcomes (7)
- measure
- The change in Bowel Function Index (BFI) score
- timeFrame
- From enrollment to two weeks after initiation of naldemedine
- measure
- A clinically meaningful improvement in constipation
- timeFrame
- From baseline to one week after treatment initiation and from baseline to two weeks after treatment initiation.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available