Overview

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.