Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
NCT ID: NCT00964431
Last Updated: 2012-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
203 participants
INTERVENTIONAL
2009-08-31
2009-12-31
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
TRIPLE
Study Groups
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Indomethacin Test (lower dose)
Indomethacin Test (lower dose)
20-mg single dose
Indomethacin Test (upper dose)
Single dose
Indomethacin Test (upper dose)
40-mg single dose
Celecoxib 400 mg
Celecoxib 400 mg
Capsules 2 x 200 mg Single-Dose
Placebo
Placebo
Capsules 2 Single-Dose
Interventions
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Celecoxib 400 mg
Capsules 2 x 200 mg Single-Dose
Placebo
Capsules 2 Single-Dose
Indomethacin Test (lower dose)
20-mg single dose
Indomethacin Test (upper dose)
40-mg 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 for at least 8 hours after dosing of the study drug
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
No
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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Other Identifiers
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IND2-08-03
Identifier Type: -
Identifier Source: org_study_id
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