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Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)

NCT01462370 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2022-02-09

Study results available
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Summary

This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.

Conditions

  • Dysmenorrhea

Interventions

DRUG

Etoricoxib

Etoricoxib 120 mg tablet given orally for one dose.

DRUG

Ibuprofen

Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.

DRUG

Placebo to etoricoxib

Placebo to etoricoxib, one tablet.

DRUG

Placebo to ibuprofen

Placebo to ibuprofen, up to four 3-capsule doses.

DRUG

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg

Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01462370 on ClinicalTrials.gov