TerminatedPhase 3

Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache

United States365 participantsStarted 2013-04-01

Plain-language summary

The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).

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;
✓. severity of headaches is historically at least moderate;
✓. duration of headaches is historically more than or equal to 4 hours, if untreated.

What they're measuring

Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours

Timeframe: Up to 4 hours post dose

Trial details

NCT IDNCT01842633

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03-31

Results submitted2016-06-02

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