Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2010-10-31
2011-04-30
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
TRIPLE
Study Groups
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Naproxen Test (lower dose)
200-mg
Naproxen Test
200-mg single dose
Naproxen Test (upper dose)
400-mg (2 x 200-mg)
Naproxen Test
400-mg (2 x 200-mg)
Naprosyn 250 mg
Naprosyn
single dose
Naprosyn 500 mg
Naprosyn
single dose
Placebo
Placebo
single dose
Interventions
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Naproxen Test
200-mg single dose
Naproxen Test
400-mg (2 x 200-mg)
Naprosyn
single dose
Naprosyn
single dose
Placebo
single dose
Eligibility Criteria
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Inclusion Criteria
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient requires extraction of 2 or more third molars
* Patient must be willing to stay at the study site overnight
Exclusion Criteria
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to screening
18 Years
50 Years
ALL
Yes
Sponsors
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Iroko Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Locations
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Premier Research Group Limited
Austin, Texas, United States
Countries
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References
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Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15.
Other Identifiers
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NAP2-08-03
Identifier Type: -
Identifier Source: org_study_id
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