Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

Summary

This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).

Timeline

Start

2009-07

Primary completion

2010-06

Completion

2010-08

Outcome

Met primary endpoint

paper The 2-sided 95% CI for the treatment difference (celecoxib - diclofenac) was -2.2 to 8.8. PMID 25516774 ↗

paper Celecoxib 200 mg once daily is noninferior to diclofenac sustained release 75 mg once daily for pain treatment in Chinese patients with AS. PMID 25516774 ↗

Publications

• Huang F, Gu J, Liu Y, Zhu P, Zheng Y, Fu J, Pan S, Le S. Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment. Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	200 mg	—
Subject	Celecoxib	Other / unclassified	400 mg	—
Comparator	Diclofenac SR	Unknown	75 mg	—

Indications