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

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Hallux Valgus
Interventions
DRUG

Tapentadol IR 50 mg

Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.

DRUG

Tapentadol IR 75 mg

Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.

DRUG

Placebo

Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.

Trial Locations (3)

Unknown

Kaohsiung City

Taipei

Taoyuan District

Sponsors
All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

Janssen-Cilag International NV

INDUSTRY