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A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain

Last updated on March 14, 2019

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Study Location
Jean Brown Research
Salt Lake City, Utah, 84124 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post-surgical Pain Following Extraction of Molar Teeth
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Outpatients who have undergone surgical extraction of 3 or more third molars, of which
at least 2 must be a partial or complete bony mandibular impaction.

- Subject must have at least moderate pain on the 4-point categorical scale, confirmed
by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less
than or equal to 5 hours, 15 minutes) after surgery is completed.

- Female subjects are not pregnant or breast feeding.

- Informed consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic
disorder determined by the Investigator to place the subject at increased risk,
including the presence or history within 2 years of screening.

- Acute localized dental alveolar infection at the time of surgery that could confound
the post-surgical evaluation.

- Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP,
tramadol, other opioids, or to their combinations.

NCT02912650
Pfizer
Completed
A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain

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[email protected]

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