drugset / Trial / NCT00410644

A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain

NCT00410644

Phase 3 Completed 463 enrolled Alza Corporation
Non-randomizedSingle-groupSingle-blindTreatment

Summary

The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS Hydromorphone HCI. The safety profile for OROS Hydromorphone HCI will also be evaluated.

Timeline

Start
Primary completion
Completion
1999-02

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.