Naldemedine's effect on constipation caused by opioids
Official title: The Effect of Naldemedine on Opioid-induced Bowel Dysfunction. An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled, Cross-over Clinical Trial
Run by Aalborg University Hospital · NCT06334198 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if Naldemedine can help young men with chronic pain who are taking tramadol avoid constipation caused by opioids.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 40 Years |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT06334198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy, opioid naïve males aged 20 to 40 of Northern European descent.
✕Probably not a fit
Patients with a history of opioid use or those with known allergies to the study medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of Naldemedine, a peripheral acting mu-receptor antagonist, in preventing opioid-induced bowel dysfunction and constipation in patients receiving tramadol for chronic pain. Given that up to 90% of patients on opioids experience constipation, this research aims to provide a solution that maintains pain relief while addressing gastrointestinal side effects. Participants will be opioid naïve males of Northern European descent, aged 20 to 40, who will receive either Naldemedine or a placebo during the study. The study will assess the impact of Naldemedine on bowel function compared to standard treatments.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for patients suffering from constipation due to opioid use, improving their quality of life.
How similar studies have gone: While the use of PAMORAs like Naldemedine is promising, this specific approach in the context of tramadol has not been extensively tested, making it a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy (assessed by a study-affiliated medical doctor) * Signed informed consent * Able to read and understand Danish. * Male (to avoid influence of menstrual cycles). * Northern European descent (to minimize genetic variance influences on drug metabolism). * The researcher believes that the participant understands the study details, is compliant and is expected to complete the study. * Opioid naïve (no history of opioid use/addiction. Opioid use more than a year ago to treat pain post-surgery is accepted. Opioid use in connection with participation in a clinical trial more than a year ago is accepted) * Between 20 and 40 years of age. * A STAI (Spielberger State-Trait Anxiety Inventory) score in the range of 20-37 i.e., classified as "no or low anxiety" at inclusion. Exclusion Criteria: Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study. * Less than three spontaneous bowel movements per week. * Participation in other studies within 14 days prior to first visit. * Expected need of medical/surgical treatment during the study. * Any diagnosed disease, which investigator concludes will affect the trial (including all contraindicated complications: severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, paralytic ileus, hypercapnia, serious respiratory depression with hypoxia, moderate to severe decreased liver function, gastrointestinal obstruction or perforation, acute surgical abdominal complications such as appendicitis, Mb. Crohn's, ulcerative colitis, and toxic mega colon). History of substance abuse (alcohol, tetrahydrocannabinol, benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start). * History of major mental disorders (e.g., major anxiety, major depression or treatment with psychoactive medications etc.) * Metal implants or pacemaker. * Daily use of prescription only medicine * Daily alcohol consumption * Participation motivated by "wrongful" reasons such as poor economy or psychosocial issues e.g., problems in the family, loneliness, sadness. People with such problems may be more likely to develop substance dependence\*. * Intake of alcohol within 48 hours before start of study period or any alcohol consumption during each study period. If consumption takes place during the study the participant will be excluded. * Use of any analgesic medication within 48 hours before start as well as for the duration of the study. If consumption takes place during the study the participant will be excluded. * Nicotine use
Where it's running
-
Aalborg University Hospital
Aalborg, Denmark Recruiting
Study contacts
- Principal investigator: Asbjørn Mohr Drewes — Aalborg University Hospital
- Study coordinator: Asbjørn Mohr Drewes
- Email: amd@rn.dk
- Phone: +45 97 66 35 62
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.