Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty

Phase 2 Completed 44 enrolled QRxPharma Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.

Timeline

Start: 2009-02
Primary completion: 2009-07
Completion: 2009-07

Publications

Richards P, Gimbel JS, Minkowitz HS, Kelen R, Stern W. Comparison of the efficacy and safety of dual-opioid treatment with morphine plus oxycodone versus oxycodone/acetaminophen for moderate to severe acute pain after total knee arthroplasty. Clin Ther. 2013 Apr;35(4):498-511. doi: 10.1016/j.clinthera.2013.03.002. Epub 2013 Mar 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	325 mg	—
Subject	Morphine	Other / unclassified	3 mg	Oral
Subject	Morphine	Other / unclassified	6 mg	Oral
Subject	Morphine	Other / unclassified	24 mg	Oral
Subject	Oxycodone	Other / unclassified	2 mg	Oral
Subject	Oxycodone	Other / unclassified	4 mg	Oral
Subject	Oxycodone	Other / unclassified	5 mg	Oral
Subject	Oxycodone	Other / unclassified	16 mg	Oral

Indications

No indication recorded.