None listed
Conditions
Interventions
Group 1 Type of group
rofecoxib 50 mg daily orally
Group name:Group 4 Type of group
Placebo daily orally
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Headache relief at 2 hours is defined as Grade 3/2 at baseline at Grade 1/0 at 2 hours Measure:Headache relief 2 hours after administration of the study drug Timepoints:2 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Sustained relief / remission of headache / pain is defined as sustained relief / remission of headache / pain at 2 hours, with no need for rescue medication or recurrence of moderate / severe headache and / or recurrence of mild / moderate headache / severe for 2 to 24 hours after dosing with the study medication. Measure:Sustained relief / remission of headache / pain within 24 hours after the dose administered. Timepoints:24 hours ; Outcome name:Presence or absence of associated symptoms such as photophobia, phonophobia, nausea or vomiting registered at 0.5, 1.0, 1.5, 2.0, 3.0 and 4.0 hours after the dose administered. Measure:Presence or absence of associated symptoms such as photophobia, phonophobia, nausea or vomiting registered at 0.5, 1.0, 1.5, 2.0, 3.0 and 4.0 hours after the dose administered. Timepoints:at 0.5, 1.0, 1.5, 2.0, 3.0 and 4.0 hours ; Outcome name:Classifications of functional disability registered at 0.5, 1.0, 1.5, 2.0, 3.0 and 4.0 hours after the dose administered. Measure:Classifications of functional disability registered at 0.5, 1.0, 1.5, 2.0, 3.0 and 4.0 hours after the dose administered. Timepoints:at 0.5, 1.0, 1.5, 2.0, 3.0 and 4.0 hours ; Outcome name:Use of rescue medications between 2 and 24 hours after the test medication. Measure:Use of rescue medications between 2 and 24 hours after the test medication. Timepoints:24 hours ; Outcome name:Recurrence of headache is defined as the reappearance of headache in Grade 2 or 3 (moderate or severe) within 24 hours of the treatment dose in patients reporting headache relief at 2 hours after the administered dose. Measure:Recurrence of headache within 24 hours after the treatment dose. Timepoints:2 hours ; Outcome name:Reappearance of mild / moderate / severe headache without pain between 2 and 24 hours after the treatment dose. Measure:Reappearance of mild / moderate / severe headache without pain betw | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed