NCT00092729

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2002

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2004

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

September 23, 2004

Last Update Submit

August 12, 2024

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

1

EXPERIMENTAL

etoricoxib

Drug: etoricoxib (MK0663)

2

PLACEBO COMPARATOR

Placebo to match etoricoxib

Drug: Comparator: placebo (unspecified)

3

ACTIVE COMPARATOR

naproxen sodium

Drug: Comparator: naproxen sodium

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

Also known as: MK0663
1
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

2
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

Also known as: naproxen sodium
3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 18 years of age or older suffering from painful menstruation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Interventions

EtoricoxibNaproxen

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2004

First Posted

September 28, 2004

Study Start

June 7, 2002

Primary Completion

December 6, 2002

Study Completion

December 6, 2002

Last Updated

August 15, 2024

Record last verified: 2022-02