Bunionectomy Study (0000-063)

PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Acute Pain
Interventions
DRUG

pregabalin

Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

DRUG

naproxen sodium

Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0.

DRUG

Comparator: Placebo

Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00601458 - Bunionectomy Study (0000-063) | Biotech Hunter | Biotech Hunter