A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

PHASE3CompletedINTERVENTIONAL
Enrollment

353

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions
Hallux Valgus
Interventions
DRUG

Tapentadol IR 50 mg

Type= exact number, unit= mg, number= 50, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.

DRUG

Tapentadol IR 75 mg

Type= exact number, unit= mg, number= 75, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.

DRUG

Placebo

Form= tablet, route= oral use. Placebo tablets will be administered as a single oral dose every 4 to 6 hours, for a period of 72 hours.

Trial Locations (7)

Unknown

Busan

Chungcheongbuk-Do

Gwangju

Gyeonggi-do

Pusan

Seoul

Ulsan

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01516008 - A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy | Biotech Hunter | Biotech Hunter