drugset / Trial / NCT00411268

Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain

NCT00411268

Phase 3 Completed 207 enrolled Alza Corporation
RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.

Timeline

Start
Primary completion
Completion
2001-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 8 mg Oral
Subject Hydromorphone Other / unclassified 16 mg Oral
Subject Hydromorphone Other / unclassified 32 mg Oral
Subject Hydromorphone Other / unclassified 64 mg Oral

Indications

No indication recorded.