An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
etoricoxib (MK0663)
Comparator: placebo (unspecified)
Comparator: naproxen sodium
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
etoricoxib
Placebo to match etoricoxib
naproxen sodium
Outcomes
Primary Outcome Measures
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 to onset, peak, and duration of the analgesic effect compared with placebo
Secondary Outcome Measures
Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium
Overall analgesic effect, time to onset, peak, and duration of analgesic effect of naproxen sodium compared with placebo
Safety and tolerability of etoricoxib as assessed by the number of patients with clinical or laboratory adverse experiences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092729
Brief Title
An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)
Official Title
A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2002 (Actual)
Primary Completion Date
December 6, 2002 (Actual)
Study Completion Date
December 6, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
etoricoxib
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo to match etoricoxib
Arm Title
3
Arm Type
Active Comparator
Arm Description
naproxen sodium
Intervention Type
Drug
Intervention Name(s)
etoricoxib (MK0663)
Other Intervention Name(s)
MK0663
Intervention Description
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
Intervention Name(s)
Comparator: placebo (unspecified)
Intervention Description
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
Intervention Name(s)
Comparator: naproxen sodium
Other Intervention Name(s)
naproxen sodium
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)
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