An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Drug: etoricoxib (MK0663)
* Drug: Comparator: placebo (unspecified)
* Drug: Comparator: naproxen sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>etoricoxib | Drug: etoricoxib (MK0663)<br>* Two etoricoxib 60 mg tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea<br>* Other names: MK0663;|
| Placebo Comparator: 2<br>Placebo to match etoricoxib | Drug: Comparator: placebo (unspecified)<br>* Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea<br>|
| Active Comparator: 3<br>naproxen sodium | Drug: Comparator: naproxen sodium<br>* Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea<br>* Other names: naproxen sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |