NCT06334198

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction. An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled, Cross-over Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Asbjørn Mohr Drewes · Academic / Other
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Opioid-Induced Bowel Dysfunction
• Constipation

Interventions

Type	Name	Description
DRUG	Naldemedine	Naldemedine is administered orally once daily in the morning in a dosage of 0.2 mg.
DRUG	Placebo	Placebo is administered orally once daily in the morning.
DRUG	Tramadol	In both arms, tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200mg).

Timeline

• Start date: 2024-03-12
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-03-27
• Last updated: 2024-03-28

Locations

1 site across 1 country: Denmark