drugset / Trial / NCT00411034

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

NCT00411034

Phase 3 Completed 463 enrolled Alza Corporation
RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic cancer 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 (slow release). The safety profile for OROS Hydromorphone HCI (slow release) will also be evaluated.

Timeline

Start
Primary completion
Completion
1999-09

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.