OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
CompletedPhase 3NCT00902837
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- 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.
- Conditions
- Chronic Osteoarthritis
- Interventions
- Drug: Oxycodone naloxone prolonged release tablets (OXN)
- Drug: oxycodone prolonged release tablet
- Drug: oxycodone naloxone tablet
- Sponsor
- Mundipharma Research GmbH & Co KG
- Start date
- 2009-05
- Primary completion
- 2010-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium, Czechia, Finland, Germany, Hungary, Spain
- Total sites listed
- 36
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria: * Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid therapy. Exclusion criteria: * Females who are pregnant or lactating. * Subjects with evidence of significant structural abnormalities of the gastrointestinal tract. * Subjects with evidence of impaired liver/kidney function upon entry into the study
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00902837