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

Summary

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

Timeline

Start

2010-04

Primary completion

2010-07

Completion

2010-08

Outcome

Met primary endpoint

registry Placebo vs Ibuprofen Sodium; p <0.001; Least-square (LS) mean difference 24.21 (95% CI 19.32 to 29.09) NCT01098747 ↗

registry Placebo vs Ibuprofen Sodium; p <0.001; Hazard Ratio (HR) 12.80 (95% CI 6.78 to 24.15) NCT01098747 ↗

registry Ibuprofen Sodium vs Ibuprofen (Advil + Motrin IB); p <0.001; Hazard Ratio (HR) 1.59 (95% CI 1.22 to 2.06) NCT01098747 ↗

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.
• Brain P, Leyva R, Doyle G, Kellstein D. Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. Clin J Pain. 2015 May;31(5):444-50. doi: 10.1097/AJP.0000000000000142.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibuprofen	Small molecule	400 mg	—
Subject	Ibuprofen	Small molecule	512 mg	—

Indications

No indication recorded.