A RANDOMIZED, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED AND PARALLEL-GROUP ACTIVE COMPARATOR STUDY TO EXAMINE THE SAFETY, TOLERABILITY AND EFFICACY OF ROFECOXIB OF 50 AND 25 MG FOR THE ACUTE TREATMENT OF MIGRAINE

Not Applicable

• Conditions: -G43; G43

• Registration Number: PER-062-01
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-10-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The patient is 18 years old, as the minimum age.
• The patient has had on average> 1 and <8 migraine attacks per month during the last 6 months, with or without aura
• The patient understands the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria

• The patient has difficulty distinguishing his migraine attacks from headaches caused by tension or at intervals.
• If a woman, if the patient is pregnant or breastfeeding, or if she is of childbearing age and is sexually active, she is not willing to use effective oral contraceptives or oral contraceptives during the study. Patients who are taking oral contraceptives and have done so for less than 2 months before entering the study.
• The patient has shown hypersensitivity, or has experienced an adverse event in response to rofecoxib or ibuprofen, or has a contraindication to the use of rofecoxib or ibuprofen (eg, allergic reaction to NSAIDs)
• The patient has clinical or laboratory evidence of uncontrolled hypertension, or pulmonary, renal, hepatic, endocrine, neurological (other than migraine), psychiatric or systemic disease, or any laboratory abnormality that, in the opinion of the investigator, may confuse the results of the study, represent an additional risk to the patient or interfere with optimal participation in the study.
• The patient has a history of alcohol or drug abuse within 1 year.
• The patient has received treatment with an experimental device or compound within 30 days of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Headache relief at 2 hours is defined as Grade 3/2 at baseline at Grade 1/0 at 2 hours<br>Measure:Headache relief 2 hours after administration of the study drug<br>Timepoints:2 hours<br>