scholarly journals Safety and efficacy from a 6-week double-blind study and a 52-week open-label extension of aripiprazole in adolescents with schizophrenia in Japan

2018 ◽  
Vol 72 (9) ◽  
pp. 701-712 ◽  
Author(s):  
Hideo Matsumoto ◽  
Jun Ishigooka ◽  
Hiroaki Ono ◽  
Yoshihiro Tadori
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Open Label ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Open Label Extension

Etanercept in the Longterm Treatment of Patients With Ankylosing Spondylitis

2009 ◽  
Vol 36 (6) ◽  
pp. 1256-1264 ◽  
Author(s):  
BEN DIJKMANS ◽  
PAUL EMERY ◽  
MARKKU HAKALA ◽  
MARJATTA LEIRISALO-REPO ◽  
EMILIO MARTIN MOLA ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Safety Data ◽  
Blind Study ◽  
Double Blind Study ◽  
Upper Respiratory Tract ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension ◽  
Tract Infections

Objective.To evaluate the 2-year efficacy and safety of etanercept in patients with ankylosing spondylitis (AS).Methods.A 96-week open-label extension study, which followed a 12-week double-blind placebo-controlled trial, was designed to provide longterm efficacy and safety data, including radiographic outcomes, for patients treated with etanercept 25 mg twice weekly (NCT00421980). In all, 81 patients were enrolled (96% of the participants from the double-blind study). Key efficacy measures included improvement using the Assessment in Ankylosing Spondylitis 20% (ASAS20) criteria, the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) method. Paired t tests were used to test within-group changes from baseline.Results.The percentage of responders, by ASAS20 criteria, remained relatively constant in patients who received etanercept during the 12-week double-blind study (60% at Week 0 and 83% at Week 96 of the open-label extension); more patients from the placebo group became responders after being switched to etanercept (23% and 74%, respectively). A similar trend was also observed using the ASAS40 and ASAS5/6 criteria, the BASFI, and the BASDAI. Most patients had no change from baseline in mSASSS values. Etanercept was well tolerated; the most frequent adverse events were injection site reactions (n = 30; 37.0%) and headache (n = 18; 22.2%), and the most frequent infections were upper respiratory tract infections (n = 43; 53.1%) and flu syndrome (n = 22; 27.2%).Conclusion.For 2 years, etanercept was clinically effective and well tolerated, with no unexpected safety findings.

Civamide Cream 0.075% in Patients with Osteoarthritis of the Knee: A 12-Week Randomized Controlled Clinical Trial with a Longterm Extension

2011 ◽  
Vol 39 (3) ◽  
pp. 610-620 ◽  
Author(s):  
THOMAS J. SCHNITZER ◽  
JEAN-PIERRE PELLETIER ◽  
DOUG M. HASELWOOD ◽  
WILLIAM T. ELLISON ◽  
JOHN E. ERVIN ◽  
...  
Keyword(s):  
Physical Function ◽  
Weighted Average ◽  
Blind Study ◽  
Womac Pain ◽  
Global Evaluation ◽  
Double Blind Study ◽  
Open Label ◽  
Double Blind ◽  
Pain Subscale ◽  
Open Label Extension

Objective.To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee.Methods.We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed.Results.A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline-by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies.Conclusion.These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments.

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