Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
NCT ID: NCT01559259
Last Updated: 2020-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
394 participants
INTERVENTIONAL
2012-04-10
2012-09-13
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
DOUBLE
Study Groups
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Ibuprofen/acetaminophen (lower dose)
Ibuprofen/acetaminophen
Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
Ibuprofen/acetaminophen (middle dose)
Ibuprofen/acetaminophen
Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg
Ibuprofen/acetaminophen (high dose)
Ibuprofen/acetaminophen
Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg
Ibuprofen
Ibuprofen
Two caplets of ibuprofen 200 mg
Placebo
Placebo
Two caplets of placebo
Interventions
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Ibuprofen/acetaminophen
Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
Ibuprofen/acetaminophen
Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg
Ibuprofen/acetaminophen
Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg
Ibuprofen
Two caplets of ibuprofen 200 mg
Placebo
Two caplets of placebo
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth
Exclusion Criteria
* Pregnant or breastfeeding females
16 Years
40 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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Jean Brown Research
Salt Lake City, Utah, United States
Countries
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References
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Kellstein D, Leyva R. Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study. Drugs R D. 2020 Sep;20(3):237-247. doi: 10.1007/s40268-020-00310-7.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B5061001
Identifier Type: -
Identifier Source: org_study_id
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