Expired Study
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Salt Lake City, Utah 84124


Purpose:

This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.


Criteria:

Inclusion Criteria: - Normal, healthy males and females 16 to 40 years of age - Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction - Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide Exclusion Criteria: - Pregnancy or breast-feeding - Alcohol or substance abuse - Any serious medical or psychiatric disorder - History of stomach ulcers, stomach bleed, or other bleeding disorders - Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol])


NCT ID:

NCT01216163


Primary Contact:

Study Director
Pfizer CT.gov Call Center
Pfizer


Backup Contact:

N/A


Location Contact:

Salt Lake City, Utah 84124
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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