Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Headache, Tension-Type

In brief

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.

Key facts

Study ID

NCT01755702

Run by

GlaxoSmithKline

People needed

66

Starts

2009-07-01

Expected to finish

2010-03-01

Last updated by the study team

2015-03-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of episodic tension-type headache consistent with all of the following:
• number of days with the condition is historically greater than or equal to two per month
• onset of condition was greater than or equal to 12 months from Visit 1
• age of onset was < 50 years
• severity of headaches is historically at least moderate
• duration of headaches is historically greater than or equal to four hours, if untreated
• 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
• treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours

You may not qualify if…

• 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

Where it is running

• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Springfield Neurology Associates — Springfield, Massachusetts, United States
• MedVadis Research Corporation — Wellesley Hills, Massachusetts, United States
• Biomedical Research Alliance of New York LLC — Lake Success, New York, United States
• Elkind Headache Center — Mount Vernon, New York, United States
• International Research Service, Inc. — Port Chester, New York, United States
• Jefferson Headache Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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