NCT01462370

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

A Phase III, Randomized, Active-Comparator-Controlled, 2-period, Crossover, Double-Blind Study in China to Assess the Safety and Efficacy of Etoricoxib 120 mg Versus Ibuprofen up to 2400 mg (600 mg Q6h) in the Treatment of Patients With Primary Dysmenorrhea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.

Detailed description

Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles. In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-10-31
• Last updated: 2022-02-09
• Results posted: 2013-07-10