Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
226 participants
INTERVENTIONAL
2011-06-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment A
Ibuprofen Sodium
Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)
Treatment B
Standard Ibuprofen
Single-dose of standard ibuprofen tablets (400mg)
Treatment C
Placebo
Single-dose of placebo
Interventions
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Ibuprofen Sodium
Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)
Standard Ibuprofen
Single-dose of standard ibuprofen tablets (400mg)
Placebo
Single-dose of placebo
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of an episodic tension-type headache, as defined by the International Headache Society
Exclusion Criteria
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Countries
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References
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Packman E, Leyva R, Kellstein D. Onset of analgesia with ibuprofen sodium in tension-type headache: a randomized trial. J Pharm Health Care Sci. 2015 Apr 2;1:13. doi: 10.1186/s40780-015-0012-9. eCollection 2015.
Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B3411007
Identifier Type: -
Identifier Source: secondary_id
AH-11-16
Identifier Type: -
Identifier Source: org_study_id
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