Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain

Phase 2 Completed 255 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.

Timeline

Start: 2010-04
Primary completion: 2010-08
Completion: 2010-08

Outcome

Met primary endpoint

registry Additional Dose Celecoxib 200 mg vs Additional Dose Placebo; p <0.0001; Risk Difference (RD) 38.2 (95% CI 20.3 to 56.1) NCT01062113 ↗

Publications

Saito K, Kaneko A, Machii K, Ohta H, Ohkura M, Suzuki M. Efficacy and safety of additional 200-mg dose of celecoxib in adult patients with postoperative pain following extraction of impacted third mandibular molar: a multicenter, randomized, double-blind, placebo-controlled, phase II study in Japan. Clin Ther. 2012 Feb;34(2):314-28. doi: 10.1016/j.clinthera.2012.01.004. Epub 2012 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	200 mg	—

Indications

No indication recorded.