Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: Etoricoxib; Ibuprofen; Placebo to etoricoxib; Placebo to ibuprofen; Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg
Intervention description: Etoricoxib 120 mg tablet given orally for one dose.; Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.; Placebo to etoricoxib, one tablet.; Placebo to ibuprofen, up to four 3-capsule doses.; 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.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Etoricoxib; Caffeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 139.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.