drugset / Trial / NCT00831051

Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

NCT00831051

Phase 2 Completed 197 enrolled QRxPharma Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

Timeline

Start
2008-12
Primary completion
2009-01
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Morphine Other / unclassified 6 mg
Comparator Morphine Other / unclassified 12 mg
Comparator Oxycodone Other / unclassified 4 mg
Comparator Oxycodone Other / unclassified 8 mg
Subject Q8003 Unknown

Indications

No indication recorded.