drugset / Trial / NCT00902837

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

NCT00902837

Phase 3 Completed 181 enrolled Mundipharma Research GmbH & Co KG
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2009-05
Primary completion
2010-04
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxycodone Other / unclassified
Subject Oxycodone naloxone Unknown

Indications