A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety

PHASE3TerminatedINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Arthroplasty
Interventions
DRUG

Tapentadol IR (CG5503)

Fixed Dose 50, 75, \& 100 mg BID for 3 days

DRUG

Placebo

Fixed Dose Matching placebo for 3 days

DRUG

Oxycodone HCL IR

Fixed Dose 10 mg BID for 3 days

DRUG

Tapentadol IR (CG5503)

Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days

Trial Locations (77)

Unknown

Birmingham

Mobile

Sheffield

Phoenix

Fort Smith

Little Rock

Anaheim

Arcadia

Glendale

Laguna Hills

Sacramento

San Francisco

Denver

Farmington

Boynton Beach

DeLand

Fort Lauderdale

Hollywood

Miami

Plantation

Port Orange

Tamarac

Decatur

Chicago

Peoria

Indianapolis

Topeka

Baltimore

Boston

Royal Oak

Albany

Mineola

Charlotte

Oklahoma City

Philadelphia

Sewickley

Nashville

Austin

Dallas

Grapevine

Houston

Lubbock

Plano

Murray

Weston

Aalst

Genk

Ghent

Leuven

Halifax

Burlington

Newmarket

Oshawa

Scarborough Village

Thunder Bay

Toronto

Montreal

London

Helsinki

Tampere

Turku

Hamilton

Cadiz

Madrid

Valencia

Borås

Hässleholm

Örebro

Uppsala

Aberdeen

Birmingham

Edinburgh

Great Yarmouth

London

Middlesex

Sheffield

Wigan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY