Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
NCT ID: NCT01077973
Last Updated: 2012-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2010-03-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment A
Novel Ibuprofen
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
Treatment B
Standard Ibuprofen
Single-dose of standard ibuprofen (400mg) plus placebo
Treatment C
Placebo
Single-dose of placebo
Interventions
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Novel Ibuprofen
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
Standard Ibuprofen
Single-dose of standard ibuprofen (400mg) plus placebo
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
* A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics
Exclusion Criteria
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
* History of stomach ulcers, stomach bleed, or other bleeding disorders
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
Countries
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References
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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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Other Identifiers
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AH-09-11
Identifier Type: -
Identifier Source: org_study_id