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

Phase 3 Completed 218 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2010-10
Primary completion: 2011-01
Completion: 2011-01

Publications

Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	1000 mg	—
Subject	Ibuprofen	Small molecule	512 mg	—

Indications

No indication recorded.