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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Acetaminophen; Caffeine; Etoricoxib; Ibuprofen

Criteria

Inclusion Criteria:

• Agree to remain abstinent or use double-barrier contraception throughout the study. Participants who are status post tubal ligation are exempt from this requirement.

• Moderate or severe primary dysmenorrhea during a minimum of 4 of the previous 6 menstrual cycles. Moderate: Over-the-counter analgesics provide significant relief in most menstrual cycles; discomfort interferes with usual activity. Severe: Over-the-counter analgesics not consistently effective, or prescription analgesics required in at least some menstrual cycles; discomfort is incapacitating causing an inability to work or do usual activity.

• Willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period as well as to avoid exercise during the first 24 hours postdose in each menstrual cycle.

• Able to read, understand, and complete diary.

Exclusion Criteria:

• Use of an intrauterine device. Pregnant, breast feeding, or <6 weeks postpartum.

• Active gastric ulcer or history of inflammatory bowel disease.

• Uncontrolled hypertension.

• Uncontrolled diabetes mellitus or renal disease.

• Class II-IV congestive heart failure.

• Coronary artery bypass graft surgery, angioplasty, myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.

• Unstable angina.

• Mild, moderate, or severe hepatic insufficiency.

• Any personal or family history of an inherited or acquired bleeding disorder.

• History of neoplastic disease; Exceptions: 1)adequately treated basal cell carcinoma or carcinoma in situ of the cervix; 2) other malignancies which have been successfully treated > or equal to 5 years prior to screening. Participants with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment.

• Allergic to etoricoxib, ibuprofen, acetaminophen, indomethacin, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or cyclooxygenase (COX)-2 inhibitors, or to components in Saridon (propyphenazone/paracetamol/caffeine).

• Recent history of chronic analgesic or tranquilizer use or dependence.

• Morbidly obese and demonstrates significant health problems stemming from the obesity.

• Current user of recreational or illicit drugs or had a recent history of drug or alcohol abuse or dependence.

• Participated in another clinical study within the last 4 weeks.

• Not able to swallow oral medications: surgical or anatomical conditions that will preclude from swallowing and absorbing oral medications on an ongoing basis.