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

• Status: Terminated
• Trial end date: 2015-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

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

1. number of days with the condition is historically greater than or equal to two per month;

2. severity of headaches is historically at least moderate;

3. duration of headaches is historically more than or equal to 4 hours, if untreated.

Exclusion Criteria:

• 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.