NCT01462370View on ClinicalTrials.gov

Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)

PHASE3CompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Dysmenorrhea
Interventions
DRUG

Etoricoxib

Etoricoxib 120 mg tablet given orally for one dose.

DRUG

Ibuprofen

Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.

DRUG

Placebo to etoricoxib

Placebo to etoricoxib, one tablet.

DRUG

Placebo to ibuprofen

Placebo to ibuprofen, up to four 3-capsule doses.

DRUG

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg

Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT01462370 - Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1) | Biotech Hunter | Biotech Hunter