Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: an 8-week open-label extension study

Efficacy and Safety of Aripiprazole for Treatment of Irritability in Children with Autistic Disorder: An Open-Label Study

Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: Results from a randomized, 52‐week, open‐label study

INTRODUCTION To examine the long-term efficacy and safety of duloxetine in the treatment of Japanese patients with diabetic neuropathic pain, we carried out a 52-week, randomized, open-label extension of a 12-week, double-blind, placebo-controlled study. MATERIALS AND METHODS Japanese adults with diabetic neuropathic pain who completed the double-blind study were eligible for this long-term s...

Long-term efficacy and safety of lumiracoxib 100 mg: an open-label extension of a 13-week randomized controlled trial in patients with primary osteoarthritis of the knee.

OBJECTIVE Osteoarthritis (OA) is a chronic condition, accompanied by inflammation and pain, and it is therefore important to demonstrate long-term efficacy and safety of treatment. Here we present data from a 39-week open-label extension to a 13-week randomized, double-blind, double-dummy, parallel-group core study. The objective was to assess the long-term safety and tolerability of lumiracoxi...

Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study

Vortioxetine is approved for the treatment of adults with major depressive disorder. This open-label extension (OLE) study evaluated the safety and tolerability of vortioxetine in the long-term treatment of major depressive disorder patients, as well as evaluated its effectiveness using measures of depression, anxiety, and overall functioning. This was a 52-week, flexible-dose, OLE study in pat...

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

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 randomize...