Study of Long-Acting Acetaminophen in Postoperative Dental Pain
NCT ID: NCT01960114
Last Updated: 2015-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
403 participants
INTERVENTIONAL
2013-10-31
2014-04-30
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
QUADRUPLE
Study Groups
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Acetaminophen ER
Acetaminophen ER
Single dose (2 tablets) Acetaminophen ER 750 mg
Placebo
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Placebo
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Interventions
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Acetaminophen ER
Single dose (2 tablets) Acetaminophen ER 750 mg
Placebo
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Eligibility Criteria
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Inclusion Criteria
* Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
* Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
* Experiencing moderate to severe pain after extraction of third molars.
Exclusion Criteria
* Cannot be pregnant (or planning to be pregnant) or nursing a baby
* Unable to swallow whole large tablets or caplets.
* Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.
17 Years
45 Years
ALL
No
Sponsors
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McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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McNeil Study Director
Role: STUDY_DIRECTOR
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Locations
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Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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AERPAI2001
Identifier Type: -
Identifier Source: org_study_id
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