Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01216163

Run by

Pfizer

People needed

218

Starts

2010-10-01

Expected to finish

2011-01-01

Last updated by the study team

2012-08-20

Who can join

Age: 16 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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])

Where it is running

• Pfizer Investigational Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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