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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Research GmbH & Co KG
• Treatments: Naloxone; Oxycodone

Criteria

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