Status:
TERMINATED
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2015
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT01842633
Start Date
April 1 2013
End Date
March 31 2015
Last Update
September 1 2017
Active Locations (1)
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1
PAREXEL International, LLC
Waltham, Massachusetts, United States, 02451