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A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in Patients With Chronic Osteoarthritis
The purpose of this study was to characterize the effectiveness and safety of OROS hydromorphone HCL and OxyContin in patients with chronic osteoarthritis (OA) of the knee or hip who are receiving chronic nonsteroidal anti-inflammatory drug (NSAID) or other nonsteroidal, non-opioid analgesic (ie, acetaminophen or aspirin) therapy.
Details
| Lead sponsor | Alza Corporation, DE, USA |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 140 |
| Completion | 2001-05 |
Conditions
- Osteoarthritis, Knee
- Osteoarthritis, Hip
Interventions
- OROS hydromorphone HCL ; OxyContin
Primary outcomes
- Two primary efficacy:The mean pain relief score at endpoint during the Maintenance Phase. The day from study medication initiation to the third day of moderate to complete pain relief on the final titrated dose during all three phases.