A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

PHASE3CompletedINTERVENTIONAL
Enrollment

901

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
ArthralgiaBunionHallux ValgusPain
Interventions
DRUG

Tapentadol (CG5503)

50mg capsule q4-6 hrs for 3 days

DRUG

Tapentadol (CG5503)

75mg capsule q4-6 hrs for 3 days

DRUG

oxycodone

10mg capsule q4-6 hrs for 3 days

DRUG

placebo

1 capsule q4-6 hrs for 3 days

Trial Locations (7)

Unknown

Glendale

Pasadena

Austin

Houston

San Antonio

San Marcos

Salt Lake City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

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

INDUSTRY