drugset
drugset / Trial / NCT00410943

Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain

NCT00410943 ↗

Phase 3 Completed 169 enrolled Alza Corporation
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to characterize a safe and effective means of conversion and titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of OROS hydromorphone HCI SR (slow release) and hydromorphone HCI IR (immediate release) following administration of approximately equivalent total daily doses and demonstrate a significant dose-response relationship between OROS hydromorphone HCI SR (slow release) for breakthrough pain medication use or alternatively, diary-based analgesic scores

Timeline

Start
—
Primary completion
—
Completion
1999-06

Drugs

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

Indications

No indication recorded.