Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery

Phase 3 Completed 382 enrolled Ortho-McNeil Janssen Scientific Affairs, LLC Grünenthal GmbH · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.

Timeline

Start: 2008-12
Primary completion: 2010-03
Completion: 2010-03

Publications

Vorsanger GJ, Klopfer AM, Xiang J, Benson CJ, Moskovitz BL, Rosenthal NR. Immediate-release tapentadol or oxycodone for treatment of acute postoperative pain after elective arthroscopic shoulder surgery: a randomized, phase IIIb study. J Opioid Manag. 2013 Jul-Aug;9(4):281-90. doi: 10.5055/jom.2013.0170.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxycodone	Other / unclassified	5 mg	Oral
Comparator	Oxycodone	Other / unclassified	10 mg	Oral
Subject	Tapentadol	Small molecule	50 mg	Oral
Subject	Tapentadol	Small molecule	100 mg	Oral

Indications

No indication recorded.