Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
Phase 3
Completed
- Conditions
- Acute Migraine
- Interventions
- Drug: Placebo
- Registration Number
- NCT01973205
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acetaminophen 250 mg and aspirin 250 mg Acetaminophen 250 mg and Aspirin 250 mg 2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg Placebo Placebo 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
- Primary Outcome Measures
Name Time Method Number of Subjects Who Are Pain Free at the 2-hour Assessment 2 hours Number of subjects who are pain free at the 2-hour assessment
Number of Subjects Who Are Nausea Free at the 2-hour Assessment 2 hours Number of subjects who are nausea free at the 2-hour assessment
- Secondary Outcome Measures
Name Time Method Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. 2 hours Number of subjects who are free of phonophobia at the 2-hour assessment.
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. 2 hours Number of subjects who are free of photophobia at the 2-hour assessment.