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An Open-Label, Repeated-Dose Trial to Characterize the Efficacy and Safety, and Impact on Quality of Life Measures of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain
The purpose of the study was to characterize the safety, effectiveness, and impact on quality of life (QOL) measures of OROS® hydromorphone HCL in patients with chronic low back pain.
Details
| Lead sponsor | Alza Corporation, DE, USA |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 207 |
| Completion | 2001-11 |
Conditions
- Low Back Pain
Interventions
- OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine
Primary outcomes
- The mean pain relief rating derived from daily recorded patient diaries during the 4 week maintenance phase;