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

PHASE3CompletedINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Postoperative Pain
Interventions
DRUG

Tapentadol IR

First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed

DRUG

Oxycodone IR

First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY