FPF3400 Phase 3 study in patients with hyposelenemia under the total parenteral nutrition therapy - A multicenter open study

Fujimoto Pharmaceutical Corporation0 个研究点目标入组 16 人开始时间: 2015年2月12日最近更新: 2023年10月17日

试验速览

Administration of FPF3400 led to a significant increase of the change in a serum selenium concentration to be evaluated as the primary endpoint.

•Main selection criteria
•Patients under only TPN therapy or under TPN and the enteral nutrition (EN) therapy in whom contents of EN have not been changed for last 4 weeks prior to initiation of FPF3400 administration, and the same contents are expected to be continued
•Patients who can be hospitalized for a fixed period
•Patients whose serum selenium concentrations are below the lower limit of the normal range
•Patients who require TPN therapy for longer than 4 weeks
•In case of infant patients with milk nutrition, for whom contents of milk have not been changed for last 4 weeks prior to initiation of FPF3400 administration

•Main exclusion criteria
•Patients who have hypersensitivity to selenium and other components
•Patients who took a hospital selenium preparation, a selenium compounded formulation, or some selenium supplementary foods for last 4 weeks prior to initiation of FPF3400 administration
•Patients during pregnancy or breastfeeding, or patients who wish to get pregnant during the study

发起方

Fujimoto Pharmaceutical Corporation