Opioid-Induced Bowel DysfunctionPhase 2NCT06334198
The Effect of Naldemedine on Opioid-induced Bowel Dysfunction
A Phase 2 study testing Naldemedine and Tramadol in people with Opioid-Induced Bowel Dysfunction and Constipation, run by Asbjørn Mohr Drewes at 1 site in Denmark.
Trial summary
Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid-Induced Bowel Dysfunction, Constipation
- What is being tested?
- Naldemedine and Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Mar 2024to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Asbjørn Mohr Drewes
About this study
Official title: The Effect of Naldemedine on Opioid-induced Bowel Dysfunction. An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled, Cross-over Clinical Trial
Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol
- Conditions
- Opioid-Induced Bowel Dysfunction, Constipation
- Being tested
- Naldemedine, Placebo, Tramadol
- Medical subject headings
- Opioid-Induced Constipation, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaldemedineDrug
Naldemedine is administered orally once daily in the morning in a dosage of 0.2 mg.
PlaceboDrug
Placebo is administered orally once daily in the morning.
TramadolDrug
In both arms, tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200mg).
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Naldemedine + tramadol Receives: Drug: Naldemedine; Drug: Tramadol |
| Placebo treatment | Placebo comparator | Placebo + tramadol Receives: Drug: Placebo; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total gastrointestinal transit time
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Measured: From day 4 to day 8
Colorectal transit time
Difference in hours from the entering in the colon of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Measured: From day 4 to day 8
Secondary outcomes (11)
Constipation symptoms
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire (ranging from 0 (symptom absent) to 4 (very severe).
Measured: From day 1 to day 10
Bowel movement frequency
Number of spontaneous bowel movements per day
Measured: From day 1 to day 10
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 (constipation) - type 7 (diarrhea))
Measured: From day 1 to day 10
Gastrointestinal symptoms
Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire (ranging from 0 (no discomfort) to 6 (very severe discomfort)
Measured: Day 1 and day 10
Opioid-induced constipation
Measured by the Bowel Function Index (BFI) questionnaire (ranging from 0 (not at all) to 100 (very strong).
Measured: Day 1 and day 10
Diagnostic evaluation of opioid-induced constipation
Assessed using the Rome IV C6 criteria
Measured: Day 10
Colonic motility patterns
Number of motility patterns in the colon measured by the 3D Transit Capsule
Measured: From day 4 to day 8
Opiate withdrawal symptoms
Measured by the Subjective Opiate Withdrawal Scale (ranging from 0 (not at all) to 4 /extremely)
Measured: Day 13, 14 or 15
Colon volume
Volumetric quantification of the colon measured using T2-weighted MRI images
Measured: Day 10
Colonic water content
Analysis of colonic water content measured using heavily T2-weighted MRI images
Measured: Day 10
Defecation assessment
Analysis of rear-front pressure during a simulated defecation using the Fecobionics device
Measured: Day 1 and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start12 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Induced Bowel DysfunctionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asbjørn Mohr Drewes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asbjørn Mohr Drewes, Aalborg University Hospital
- Investigators
- Asbjørn Mohr Drewes, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334198
- Sponsor's protocol ID
- Naldemedine_OIBD
- Other IDs
- 2023-507744-36-00, 2023
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Naldemedine on Opioid-induced Bowel Dysfunction. An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled, Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT06334198
- Acronym / sponsor ID
- Naldemedine_OIBD
- Conditions
- Opioid-Induced Bowel Dysfunction, Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asbjørn Mohr DrewesUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 27 Mar 2024 (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.
Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Drug: Naldemedine, Drug: TramadolNaldemedine + tramadol |
| Placebo treatment | Placebo comparator | Drug: Placebo, Drug: TramadolPlacebo + tramadol |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (14 listed)
- 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).
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 |
|---|---|---|
| NaldemedineNaldemedine is administered orally once daily in the morning in a dosage of 0.2 mg. | Drug | Active treatment |
| PlaceboPlacebo is administered orally once daily in the morning. | Drug | Placebo treatment |
| TramadolIn both arms, tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200mg). | Drug | Active treatment, Placebo treatment |
Primary outcome
Total gastrointestinal transit time
Time frame: From day 4 to day 8
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Colorectal transit time
Time frame: From day 4 to day 8
Difference in hours from the entering in the colon of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
11 secondary outcomes
Constipation symptoms
Time frame: From day 1 to day 10
Bowel movement frequency
Time frame: From day 1 to day 10
Stool consistency
Time frame: From day 1 to day 10
Gastrointestinal symptoms
Time frame: Day 1 and day 10
Opioid-induced constipation
Time frame: Day 1 and day 10
Diagnostic evaluation of opioid-induced constipation
Time frame: Day 10
Colonic motility patterns
Time frame: From day 4 to day 8
Opiate withdrawal symptoms
Time frame: Day 13, 14 or 15
Colon volume
Time frame: Day 10
Colonic water content
Time frame: Day 10
Defecation assessment
Time frame: Day 1 and day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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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. This study is not recruiting at the moment.
Asbjørn Mohr Drewes principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naldemedine and Tramadol in people with Opioid-Induced Bowel Dysfunction and Constipation, run by Asbjørn Mohr Drewes at 1 site in Denmark.
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asbjørn Mohr Drewes (+45 97 66 35 62, amd@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total gastrointestinal transit time (time frame: From day 4 to day 8). The study lists 2 primary outcomes in all. 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 28 Mar 2024.