Clinical drug investigation
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A non-oncology dose selection phase II trial tests multiple active doses in a controlled fashion, and it not only needs to determine whether the treatment is effective but also to select the 'lowest efficacious' dose if the treatment is indeed efficacious. Few approaches exist in the literature for designing phase II non-oncology dose selection trials, and the standard design with a fixed sample size has been widely used. The objective of this study was to develop a more efficient design for phase II dose selection trials that terminates the trial early for futility and adjusts the sample size and number of doses at interim analyses when appropriate. ⋯ Once a confident answer to either or both of these questions can be obtained, the trial may either be terminated early or some of the lower doses may be dropped to prevent assigning more patients to inferior doses and thus reduce the total sample size needed. Theoretical analyses and simulation studies show that the proposed adaptive design significantly outperforms the standard design with a fixed sample size. The proposed adaptive design should be preferred over the standard design especially in cases where enrolment is slow and efficacy can be measured after a relatively short period of time.
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Randomized Controlled Trial Comparative Study
Effects of sugammadex doses up to 32 mg/kg alone or in combination with rocuronium or vecuronium on QTc prolongation: a thorough QTc study.
Sugammadex reverses the effects of rocuronium- and vecuronium-induced neuromuscular blockade, which are achieved by encapsulation. It is known that some non-antiarrhythmic drugs have the potential to delay cardiac repolarization and it is therefore recommended that the effects of all new drugs on the QT interval are assessed. ⋯ Based on the results of this study of healthy subjects, it can be concluded that sugammadex alone or in combination with rocuronium or vecuronium is not associated with QTc prolongation.
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low back pain is one of the most common reasons for outpatient consultation in both the primary-care and specialized-care settings. However, few studies have explored the effect of pregabalin in this context. ⋯ compared with usual care, addition of pregabalin to existing therapy for refractory low back pain was associated with a larger reduction in pain severity and lost workday equivalents. The acquisition cost of pregabalin was offset by a higher reduction in the indirect components of cost, resulting in a significant decrease in total costs.