The Effect of Naldemedine on Opioid-induced Bowel Dysfunction
2 other identifiers
interventional
20
1 country
1
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2024
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2024
CompletedFirst Submitted
Initial submission to the registry
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 28, 2024
March 1, 2024
12 months
March 20, 2024
March 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Total gastrointestinal transit time
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
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
From day 4 to day 8
Secondary Outcomes (11)
Constipation symptoms
From day 1 to day 10
Bowel movement frequency
From day 1 to day 10
Stool consistency
From day 1 to day 10
Gastrointestinal symptoms
Day 1 and day 10
Opioid-induced constipation
Day 1 and day 10
- +6 more secondary outcomes
Study Arms (2)
Active treatment
ACTIVE COMPARATORNaldemedine + tramadol
Placebo treatment
PLACEBO COMPARATORPlacebo + tramadol
Interventions
Naldemedine is administered orally once daily in the morning in a dosage of 0.2 mg.
In both arms, tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200mg).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg University Hospital
Aalborg, 9000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asbjørn Mohr Drewes
Aalborg University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 20, 2024
First Posted
March 27, 2024
Study Start
March 12, 2024
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
March 28, 2024
Record last verified: 2024-03