A Phase 2 interventional study of Naldemedine and Placebo in Opioid-Induced Bowel Dysfunction and Constipation, sponsored by Asbjørn Mohr Drewes. Recruiting at 1 site in Denmark. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Asbjørn Mohr Drewes · Phase 2, Interventional, and Treatment
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
964 studies on the registry are indexed under Intestinal Diseases; 176 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Asbjørn Mohr Drewes is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study.
History of substance abuse (alcohol, tetrahydrocannabinol, benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start).
Naldemedine + tramadol
Drug: Naldemedine · Drug: Tramadol
Placebo + tramadol
Drug: Placebo · Drug: Tramadol
Naldemedine is administered orally once daily in the morning in a dosage of 0.2 mg.
Placebo is administered orally once daily in the morning.
In both arms, tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200mg).
Total gastrointestinal transit time
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Time frame: 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
Time frame: From day 4 to day 8
Constipation symptoms
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire (ranging from 0 (symptom absent) to 4 (very severe).
Time frame: From day 1 to day 10
Bowel movement frequency
Number of spontaneous bowel movements per day
Time frame: From day 1 to day 10
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 (constipation) - type 7 (diarrhea))
Time frame: 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)
Time frame: 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).
Time frame: Day 1 and day 10
Diagnostic evaluation of opioid-induced constipation
Assessed using the Rome IV C6 criteria
Time frame: Day 10
Colonic motility patterns
Number of motility patterns in the colon measured by the 3D Transit Capsule
Time frame: 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)
Time frame: Day 13, 14 or 15
Colon volume
Volumetric quantification of the colon measured using T2-weighted MRI images
Time frame: Day 10
Colonic water content
Analysis of colonic water content measured using heavily T2-weighted MRI images
Time frame: Day 10
Defecation assessment
Analysis of rear-front pressure during a simulated defecation using the Fecobionics device
Time frame: Day 1 and day 10
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Asbjørn Mohr Drewes