NCT01082471

An Efficacy and Safety Study to Compare Morphine 6-glucuronide (M6G) and Morphine in Patients Suffering With Post-Operative Pain for at Least 24 Hours

A Randomised Double-blind Study to Compare the Analgesic Efficacy and Safety Profiles of M6G and Morphine, as a Loading Dose Followed by PCA, in Patients Suffering Moderate to Severe Post-operative Pain Requiring PCA for at Least 24 Hours

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 517 (actual)
• Sponsor: Paion UK Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Morphine 6-glucuronide
DRUG	Morphine

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-11-01
• Completion: 2006-12-01
• First posted: 2010-03-08
• Last updated: 2023-08-29

Locations

7 sites across 6 countries: Czechia, France, Germany, Netherlands, Poland, United Kingdom