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

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

Outcome

Met primary endpoint

registry Placebo vs Ibuprofen Sodium; p <0.001; Least-squares (LS) mean difference 17.68 (95% CI 13.08 to 22.27) NCT01216163 ↗

registry Placebo vs Ibuprofen Sodium; p <0.001; Hazard Ratio (HR) 11.84 (95% CI 5.13 to 27.36) NCT01216163 ↗

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.