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

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

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 Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: etoricoxib (MK0663); Drug: Comparator: placebo (unspecified); Drug: Comparator: naproxen sodium

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; etoricoxib	Drug: 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; Other Names: MK0663
Placebo Comparator: 2; Placebo to match etoricoxib	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
Active Comparator: 3; naproxen sodium	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; Other Names: naproxen sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2002
• Primary Completion (Actual): December 6, 2002
• Study Completion (Actual): December 6, 2002

Study Registration Dates

• First Submitted: September 23, 2004
• First Submitted That Met QC Criteria: September 27, 2004
• First Posted (Estimate): September 28, 2004

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Naproxen; Etoricoxib
• Other Study ID Numbers: 0663-064; MK0663-064; 2004_053

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis