drugset / Trial / NCT06334198

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

NCT06334198

Phase 2 Unknown 20 enrolled Asbjørn Mohr Drewes
RandomizedCrossoverDouble-blindTreatment

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

Timeline

Start
2024-03-12
Primary completion
2025-03
Completion
2025-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naldemedine Other / unclassified 0.2 mg Oral
Comparator Tramadol Other / unclassified 100 mg Oral