Study of Naproxen Capsules to Treat Dental Pain

Phase 2 Completed 254 enrolled Iroko Pharmaceuticals, LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.

Timeline

Start: 2010-10
Primary completion: 2011-04
Completion: 2011-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Naproxen Test (Upper Dose) vs Placebo; p <0.001; Mean Difference (Net) 22.417 (95% CI 16.923 to 27.910); ANCOVA NCT01229228 ↗

paper groups experienced greater pain relief over 12 h compared with placebo (P < 0.001). PMID 24127200 ↗

Publications

Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naproxen	Small molecule	200 mg	—
Subject	Naproxen	Small molecule	250 mg	—
Subject	Naproxen	Small molecule	400 mg	—
Subject	Naproxen	Small molecule	500 mg	—

Indications

No indication recorded.