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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
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 23, 2004
    Last Updated
    February 4, 2022
    Sponsor
    Organon and Co
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    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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