A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

1,123

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Osteoarthritis, HipOsteoarthritis, KneeLower Back PainPain
Interventions
DRUG

Oxycodone CR

Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.

DRUG

Tapentadol (CG5503) ER

Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.

Trial Locations (52)

Unknown

Mesa

Tucson

Anaheim

Cudahy

Encinitas

San Diego

Westlake Village

Trumbull

Chiefland

Clearwater

Jacksonville

Oldsmar

Atlanta

Cumming

Decatur

Perry

Suwanee

Woodstock

Indianapolis

Prairie Village

Topeka

Paducah

Baton Rouge

Rockville

Wellesley Hills

Kalamazoo

Las Vegas

Mamaroneck

Williamsville

Raleigh

Winston-Salem

Kettering

Medford

Duncansville

Philadelphia

Pittsburgh

Greenville

Houston

San Antonio

Roanoke

Edmonton

Coquitlam

Halifax

Corunna

Greater Sudbury

Mississauga

Sarnia

Toronto

Vancouver

Pointe-Claire

Trois-Rivières

Saskatoon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

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

INDUSTRY