Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Launched by GLAXOSMITHKLINE · Dec 19, 2012

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Eligibility criteria

• Inclusion Criteria:
• * Diagnosis of episodic tension-type headache consistent with all of the following:
• • 1. number of days with the condition is historically greater than or equal to two per month
• • 2. onset of condition was greater than or equal to 12 months from Visit 1
• • 3. age of onset was \< 50 years
• • 4. severity of headaches is historically at least moderate
• • 5. duration of headaches is historically greater than or equal to four hours, if untreated
• • 6. number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1
• • 7. treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours
• Exclusion Criteria:
• • Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
• • If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications