TerminatedPhase 2/3

Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Stopped: Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.

United States66 participantsStarted 2009-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Time to First Perceptible Headache Relief

Timeframe: Baseline to 6 hours

Trial details

NCT IDNCT01755702

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03

Results submitted2014-01-16

View on ClinicalTrials.gov More Headache, Tension-Type trials