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A Phase 3, Randomized, Double-Blind, Fixed-Dose, Parallel Group Comparison of Controlled-Release Hydromorphone HCI vs Placebo in Subjects With Osteoarthritis
The purpose of this study was to compare the analgesic (a drug that relieves pain) effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo (no drug) in patients with osteoarthritis (OA).
Details
| Lead sponsor | Alza Corporation, DE, USA |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 990 |
| Start date | 2003-11 |
| Completion | 2005-05 |
Conditions
- Osteoarthritis, Hip
- Osteoarthritis, Knee
Interventions
- OROS hydromorphone HCI (slow release)
Primary outcomes
- Time-interval weighted AUC pain ratio (AUC/by an individual's maximum possible benefit AUC)using Baseline Observation Carried Forward imputation(up to Week 12); AUC was the cumulative pain intensity differences from baseline (titration and maintenance).