drugset / Trial / NCT01280331

Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients

NCT01280331

Phase 3 Completed 375 enrolled QRxPharma Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.

Timeline

Start
2011-01
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Morphine Other / unclassified 12 mg
Subject Morphine Other / unclassified 24 mg
Subject Oxycodone Other / unclassified 8 mg
Subject Oxycodone Other / unclassified 16 mg

Indications

No indication recorded.