A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.

Key facts

Study ID

NCT02837952

Run by

Pfizer

People needed

123

Starts

2016-08-31

Expected to finish

2017-02-01

Last updated by the study team

2018-03-05

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females 18 years to 40 years of age (inclusive).
• 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 (ie, less than or equal to 5 hours, 15 minutes) after surgery is completed.
• In general good health and have no contraindications to the study or rescue medication.

You may not qualify if…

• 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 of the following medical conditions/disorders:
• Gastrointestinal ulcer or gastrointestinal bleeding;
• Paralytic ileus or other gastrointestinal obstructive disorders;
• Bleeding disorder.
• Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
• Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.

Where it is running

• Pharmaceutical Research Associates, Inc. — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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