The first study (Part A) was a double-blind and placebo-controlled 6-week trial, in which patients were randomized
to receive a self-injected 160 milligram (mg) dose of the IL-1 Trap or placebo once a week.
Until the PROTECT trial, there have been no large, randomized
clinical trials that have focused primarily on the safety of drug-eluting stents or that have provided head-to-head analysis with a specific safety outcome as a primary endpoint," said Dr.
The purpose of this study is to assess the safety and efficacy of CORTOSS([R])for the treatment of osteoporotic vertebral compression fractures as compared to commercially available PMMA bone cement via an FDA IDE pivotal, prospective, randomized
Patients were randomized
1:1:1 to receive intravitreal ranibizumab injections (0.
Eighty-six patients randomized
to receive three years of treatment in the once-daily Viread arm of Study 903 were rolled over into Study 903E and continued on the same regimen for two additional years.
As the first step in its subsequent development plans, Medivation today also announced that in the second quarter of 2006 it initiated a double-blinded extension study which allows patients from the Phase 2 study to continue treatment for up to a total of 12 months in the same treatment group to which they originally were randomized
As of September 1, 2006, 37 patients have been randomized
to drug in the Phase 2 Proellex(TM) endometriosis study at 3 active clinical sites.
Department of Education is increasingly recognizing the value of randomized
13) This acceptance is based on the results of two published randomized
trials: the Department of Veterans Affairs Laryngeal Cancer Study (1) and the European Organization for Research and Treatment of Cancer (EORTC) phase III trial.
In a prospective, randomized
clinical trial of catheters in place for an average of 6 to 7 days, minocycline-rifampin-impregnated catheters were associated with lower incidence of infection than chlorhexidine-silver sulfadiazine-impregnated catheters (RR 0.
In this study 2527 patients were randomized
to receive Remune plus an adjuvant (a substance intended to increase the effect of the vaccine) or just the adjuvant as a control.
Underlying the debate was the expectation that the results of randomized
clinical trials reported at the ASCO meeting would finally provide scientific data to resolve the frequently emotional controversy.