CancerNOCONNCT07231796
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
An observational study of Cancer and Opioid Induced Constipation (OIC), run by Professor Monique A. H. Steegers at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Opioid Induced Constipation (OIC)
- What is being tested?
- Naldemedine, an peripherally acting opioid antagonist
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jan 2026to 15 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Josje Evers, MD, +31650087799, j.evers@amsterdamumc.nl
About this study
Official title: 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.
- Conditions
- Cancer, Opioid Induced Constipation (OIC)
- Being tested
- Naldemedine, an peripherally acting opioid antagonist
- Medical subject headings
- Neoplasms, Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naldemedine, an peripherally acting opioid antagonistDrug
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollement to one week after initiation of naldemedine treatment
Secondary outcomes (7)
The change in Bowel Function Index (BFI) score
Measured: From enrollment to two weeks after initiation of naldemedine
A clinically meaningful improvement in constipation
The proportion of patients achieving a ≥12-point decline in the Bowel Function Index (BFI) score.
Measured: 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
Measured: From enrollment to two weeks of treatment
The change in Patient Assessment of Constipation, Quality of Life (PAC-QoL) scores
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.
Measured: From enrollment to two weeks of treatment with naldemedine
Continuation of naldemedine
Measured: From enrollment to two weeks after initiation of naldemedine
Patient Satisfaction
Patient satisfaction is measured on an 11-point Likert scale (0 = "Not satisfied at all", 10 = "Very satisfied").
Measured: From enrollment to two weeks of treatment with naldemedine
Patient likelihood to recommend the use of naldemedine to other patients
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.
Measured: From enrollment to two weeks of treatment with naldemedine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start2 Jan 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Monique A. H. Steegers
- Sponsor type
- University, hospital or other
- Collaborators
- Viatris Inc.
- Responsible party
- Sponsor-investigator, Professor Monique A. H. Steegers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231796
- Sponsor's protocol ID
- 2025.0837
- Acronym
- NOCON
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced Constipation: Clinical Outcomes and Patient Experience
- ClinicalTrials.gov ID
- NCT07231796
- Acronym / sponsor ID
- NOCON / 2025.0837
- Conditions
- Cancer, Opioid Induced Constipation (OIC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Professor Monique A. H. SteegersUniversity, hospital or other
- Collaborators
- Viatris Inc.
- Study start
- 2 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naldemedine, an peripherally acting opioid antagonistParticipants 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). | Drug | – |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Opioid Induced Constipation (OIC), run by Professor Monique A. H. Steegers at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josje Evers, MD (+31650087799, j.evers@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Bowel Function Index (BFI) score (time frame: From enrollement to one week after initiation of naldemedine treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.