Paracetamol With Caffeine to Treat Episodic Tension Type Headache

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Acetaminophen; Caffeine; Ibuprofen

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