A Study to Test the Safety and Effectiveness of MK0974 co-Administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura
- Conditions
- Health Condition 1: G439- Migraine, unspecifiedHealth Condition 2: null- Patients With Migraine With or Without Aura
- Registration Number
- CTRI/2009/091/000291
- Lead Sponsor
- Merck Co Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 628
Must be 18 years of age or older
History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
Willing to stay awake for at least 2 hours after taking study drug
Able to read, understand and complete questionnaires and diaries
Breast-feeding, pregnant, or plan to become pregnant during the study
Not able to tell migraine attack from other headaches
Older than 50 years of age at migraine onset
Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
History of gastric or small intestinal surgery
History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
Currently participating or have participated in a study with in investigational compound or device in the last 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of MK0974 in the treatment of migraine when co-administered with acetaminophen or ibuprofen compared to MK0974 alone and compared to placebo.Timepoint: [ Time Frame: Pain freedom two hours post dose ] [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method Test the safety and tolerability of MK0974 when co-administered with acetaminophen or ibuprofen in the treatment of acute migraine.Timepoint: [ Time Frame: Up to 2 weeks after study drug administration. ] [ Designated as safety issue: Yes ]