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

Phase 3

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: etoricoxib (MK0663)

• Registration Number: NCT00092729
• Lead Sponsor: Organon and Co

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-07
• Primary Completion: 2002-12-06
• Study Completion: 2002-12-06
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	etoricoxib (MK0663)	etoricoxib

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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