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

Organon and Co129 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

129

Conditions

Dysmenorrhea

Interventions

etoricoxib (MK0663)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

Comparator: placebo (unspecified)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

Comparator: naproxen sodiumDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: 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

Time frame: 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

Time frame: From randomization through 14 days following the last dose of study medication

Data from ClinicalTrials.gov

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