NCT06385561

The Influence of Tramadol on Opioid-induced Bowel Dysfunction

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

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

Summary

Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers.

Conditions

• Opioid-Induced Bowel Dysfunction
• Constipation

Interventions

Type	Name	Description
DRUG	Tramadol	Tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200 mg)
DRUG	Placebo	Placebo is administered orally twice daily.

Timeline

• Start date: 2022-08-11
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2024-04-26
• Last updated: 2024-04-26

Locations

1 site across 1 country: Denmark