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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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).

Key facts

Study ID

NCT01842633

Run by

GlaxoSmithKline

People needed

365

Starts

2013-04-01

Expected to finish

2015-03-31

Last updated by the study team

2017-09-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants in good general health, and with diagnosis of ETTH with following conditions:
• 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.

You may not qualify if…

• Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
• Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
• Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.

Where it is running

• PAREXEL International, LLC — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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