New hope for cancer patients suffering from painkiller side effects
NCT ID NCT07231796
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a medicine called naldemedine for constipation caused by opioids (strong painkillers) in people with cancer. About 100 adults with cancer who take opioids and still have constipation despite laxatives will receive naldemedine. Researchers will measure how well it relieves constipation and how patients feel during treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC
RECRUITINGAmsterdam, Netherlands
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