Drugs in R&D
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Randomized Controlled Trial Multicenter Study Comparative Study
Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial.
Fluid retention is a common adverse event in patients who receive endothelin (ET) receptor antagonist therapy, including the highly selective ETA receptor antagonist, atrasentan. ⋯ We conclude that thoracic bioimpedance did not reflect changes in weight gain or edema with atrasentan treatment in this study. However, the sample size was small, and it may be of interest to explore the use of thoracic bioimpedance in a larger population to understand its potential clinical use in monitoring fluid retention in patients with chronic kidney disease who receive ET receptor antagonists.
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Multicenter Study
Effect of Food on the Pharmacokinetics of the Investigational Aurora A Kinase Inhibitor Alisertib (MLN8237) in Patients with Advanced Solid Tumors.
This study was conducted to characterize the effects of food on single-dose pharmacokinetics (PK) of the investigational Aurora A kinase inhibitor alisertib (MLN8237) in patients with advanced solid tumors. ⋯ NCT00962091.
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Multicenter Study Clinical Trial
A multicenter, open-label study of an intravenous short-acting β1-adrenergic receptor antagonist landiolol hydrochloride for coronary computed tomography angiography by 16-slice multi-detector computed tomography in Japanese patients with suspected ischemic cardiac disease.
During coronary computed tomography (CT) angiography (CCTA), β-blockers (β-adrenergic receptor antagonists) have commonly been used to lower heart rate and improve image quality. ⋯ Landiolol hydrochloride was confirmed to reduce heart rate significantly and rapidly after intravenous injection and this suggests that the study drug is a safe and useful agent for improving the image quality of CCTA by 16-slice MDCT.
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Multicenter Study Clinical Trial
Inhaler competence and patient satisfaction with Easyhaler®: results of two real-life multicentre studies in asthma and COPD.
The aim of this study was to investigate patients' inhaler competence and satisfaction with the Easyhaler(®) dry powder inhaler. ⋯ Investigators found Easyhaler(®) easy to teach and patients found it easy to use, and their satisfaction with the device was high.
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Multicenter Study Clinical Trial
Efficacy and tolerability of lacosamide in the concomitant treatment of 130 patients under 16 years of age with refractory epilepsy: a prospective, open-label, observational, multicenter study in Spain.
The safety and effectiveness of lacosamide, an antiepileptic drug (AED) that selectively enhances the slow inactivation of voltage-gated sodium channels without affecting rapid inactivation, has been demonstrated in randomized, double-blind, placebo-controlled trials in adults with focal epileptic seizures. Although lacosamide is approved for use in patients over 16 years of age, limited clinical experience exists for younger patients. ⋯ The results of this study provide preliminary evidence for the efficacy of lacosamide in children with refractory epilepsy. Further evaluation in a randomized, controlled trial is needed to validate the efficacy in this population and to fully investigate the adverse effects described here. We recommend an initial dose of 1-2 mg/kg/day, uptitrated to 6-9 mg/kg/day over 4-6 weeks.