A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea
Overview
- Phase
- Phase 3
- Intervention
- etoricoxib (MK0663)
- Conditions
- Dysmenorrhea
- Sponsor
- Organon and Co
- Enrollment
- 129
- Primary Endpoint
- Overall analgesic effect as measured by the total pain relief score over 8 hours post dose (TOPAR8), sum of pain intensity difference over 8 hours post dose (SPID8), and patient's global evaluation at 8 and 24 hours post dose compared with placebo
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women 18 years of age or older suffering from painful menstruation
Exclusion Criteria
- •Women taking medications that are not allowed in the study (such as pain medications, antidepressants, tranquilizers, hypnotics, sedatives, or oral contraceptives).
- •Women who are pregnant, breast-feeding or within 6 weeks of giving birth
Arms & Interventions
1
etoricoxib
Intervention: etoricoxib (MK0663)
Outcomes
Primary Outcomes
Overall analgesic effect as measured by the total pain relief score over 8 hours post dose (TOPAR8), sum of pain intensity difference over 8 hours post dose (SPID8), and patient's global evaluation at 8 and 24 hours post dose compared with placebo
Time Frame: Up to 8 hours postdose and at 8 and 24 hours postdose, following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Time to onset, peak, and duration of the analgesic effect compared with placebo
Time Frame: to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Secondary Outcomes
- Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium(Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles)
- Overall analgesic effect, time to onset, peak, and duration of analgesic effect of naproxen sodium compared with placebo(Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles)
- Safety and tolerability of etoricoxib as assessed by the number of patients with clinical or laboratory adverse experiences(From randomization through 14 days following the last dose of study medication)