drugset
drugset / Trial / NCT00410540

A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.

NCT00410540 ↗

Phase 3 Completed 202 enrolled Alza Corporation
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and morphine (immediate-release \[IR\] and sustained-release \[SR\] formulations) using the "worst pain in the past 24 hours" item of the Brief Pain Inventory (BPI). The secondary objective of this study was to compare hydromorphone and morphine in the following variables: other pain measures, various questionnaires, and safety and tolerability variables.

Timeline

Start
—
Primary completion
—
Completion
2001-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 2 mg Oral
Subject Hydromorphone Other / unclassified 4 mg Oral
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
Subject Morphine Other / unclassified 5 mg Oral
Subject Morphine Other / unclassified 10 mg Oral
Subject Morphine Other / unclassified 20 mg Oral
Subject Morphine Other / unclassified 30 mg Oral
Subject Morphine Other / unclassified 50 mg Oral
Subject Morphine Other / unclassified 60 mg Oral
Subject Morphine Other / unclassified 90 mg Oral
Subject Morphine Other / unclassified 120 mg Oral
Subject Morphine Other / unclassified 160 mg Oral
Subject Morphine Other / unclassified 200 mg Oral

Indications

No indication recorded.