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NCT Number: NCT07231796

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

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.

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Key information

Conditions

Cancer Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Neoplasms Opioid Induced Constipation (OIC) Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. The change in Bowel Function Index (BFI) score

    Time frame: From enrollement to one week after initiation of naldemedine treatment

    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

  1. The change in Bowel Function Index (BFI) score

    Time frame: From enrollment to two weeks after initiation of naldemedine

  2. 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 proportion of patients achieving a ≥12-point decline in the Bowel Function Index (BFI) score.

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

    Time frame: From enrollment to two weeks of treatment

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

    Time frame: From enrollment to two weeks of treatment with naldemedine

    The Patient Assessment of Constipation - Quality of Life (PAC-QoL) questionnaire is a 28-item questionnaire measuring the impact of constipation on daily functioning and well-being. Responses are given on a 5-point Likert scale, with higher scores indicating greater burden.

  5. Continuation of naldemedine

    Time frame: From enrollment to two weeks after initiation of naldemedine

  6. Patient Satisfaction

    Time frame: From enrollment to two weeks of treatment with naldemedine

    Patient satisfaction is measured on an 11-point Likert scale (0 = "Not satisfied at all", 10 = "Very satisfied").

  7. Patient likelihood to recommend the use of naldemedine to other patients

    Time frame: From enrollment to two weeks of treatment with naldemedine

    Net Promoter Score (NPS): Based on the question: "How likely are you to recommend naldemedine to another patient?" (0 = "Not likely at all", 10 = "Very likely"). NPS is calculated as the percentage of promoters (scores 9-10) minus detractors (scores 0-6), yielding a score between -100 and +100.

Study contacts

Contact information is provided by the study sponsor or research team.

Josje Evers, MD

CONTACT

[email protected]

+31650087799

Sponsors and collaborators

Lead sponsor

Professor Monique A. H. Steegers

Other

Collaborators

  • Viatris Inc.

Registry information

Acronym: NOCON

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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