NCT00902837

OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects

Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee &/or Hip Taking Oxycodone Equivalent of 20 - 80 mg/Day as Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Subjects Taking Oxycodone Prolonged Release Tablets (OxyPR) Alone.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives are * to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function. * to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone

Detailed description

Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets (OxyPR) alone to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function and to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation compared to subjects taking OxyPR alone.

Conditions

• Chronic Osteoarthritis

Interventions

Type	Name	Description
DRUG	Oxycodone naloxone prolonged release tablets (OXN)
DRUG	oxycodone prolonged release tablet
DRUG	oxycodone naloxone tablet

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-04-01
• Completion: 2010-07-01
• First posted: 2009-05-15
• Last updated: 2018-10-22

Locations

36 sites across 6 countries: Belgium, Czechia, Finland, Germany, Hungary, Spain