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.

ABSTRACT:

Background

Nonsteroidal anti-inflammatory drugs are the first-line option for treating ankylosing spondylitis (AS) in China. However, no large-scale controlled trials have been conducted in this ethnic population.

Objective

To evaluate the efficacy and safety of 6 weeks' treatment with celecoxib in patients with AS in China.

Methods

This Phase 3, double-blind, parallel-group study randomized patients with AS aged ≥18 to 65 years 1:1 to receive celecoxib 200 mg once daily or diclofenac sustained release 75 mg once daily. After 6 weeks, patients could use celecoxib 400 mg once daily or maintain blinded therapy. The primary efficacy end point was mean change from baseline at Week 6 for Patient's Global Assessment of Pain Intensity score (100-mm visual analog scale). Noni

SUBMITTER: Huang F 

PROVIDER: S-EPMC4266770 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature