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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-07

Study Completion Date

2002-12-06

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).

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Detailed Description

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Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

etoricoxib

Group Type EXPERIMENTAL

etoricoxib (MK0663)

Intervention Type DRUG

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

2

Placebo to match etoricoxib

Group Type PLACEBO_COMPARATOR

Comparator: placebo (unspecified)

Intervention Type DRUG

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

3

naproxen sodium

Group Type ACTIVE_COMPARATOR

Comparator: naproxen sodium

Intervention Type DRUG

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

Interventions

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etoricoxib (MK0663)

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

Intervention Type DRUG

Comparator: placebo (unspecified)

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

Intervention Type DRUG

Comparator: naproxen sodium

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

Intervention Type DRUG

Other Intervention Names

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MK0663 naproxen sodium

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No