Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain
NCT ID: NCT03566979
Last Updated: 2020-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
501 participants
INTERVENTIONAL
2018-08-13
2019-04-15
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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Test naproxen sodium tablet
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX)
Test naproxen sodium tablet
Single dose of 2 test naproxen sodium 220 mg tablets
Commercial naproxen sodium tablet
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets
Commercial naproxen sodium tablet
Single dose of 2 naproxen sodium 220 mg tablets
Commercial naproxen sodium liquid gels capsule
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules
Commercial naproxen sodium liquid gels capsule
Single dose of 2 naproxen sodium 220 mg liquid gel capsules
Placebo tablet
Single dose of two Placebo tablets
Placebo tablet
2 placebo tablets
Interventions
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Test naproxen sodium tablet
Single dose of 2 test naproxen sodium 220 mg tablets
Commercial naproxen sodium tablet
Single dose of 2 naproxen sodium 220 mg tablets
Commercial naproxen sodium liquid gels capsule
Single dose of 2 naproxen sodium 220 mg liquid gel capsules
Placebo tablet
2 placebo tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
3. Dental extraction of three or four third molars
4. Meets post-surgical pain
5. Females of childbearing potential and males agree to contraceptive requirements of study
6. Have a negative urine drug screen at screening, and on day of surgical procedure
Exclusion Criteria
2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, hydrocodone or other opioids
3. Not able to swallow large tablets or capsules
4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
5. Use analgesics 5 or more times per week
6. History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years
7. Use of immunosuppressive drugs within 2 weeks of screening
8. History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
17 Years
50 Years
ALL
No
Sponsors
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Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
INDUSTRY
Responsible Party
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Principal Investigators
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Todd M Bertoch, MD
Role: PRINCIPAL_INVESTIGATOR
JBR Clinical Research
Locations
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JBR Clinical Research
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CCSPAA000457
Identifier Type: -
Identifier Source: org_study_id
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