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

Phase 3

Completed

• Conditions: Hyposelenemia

• Registration Number: JPRN-jRCT2080222751
• Lead Sponsor: Fujimoto Pharmaceutical Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Study Completion: 2015-07-16
• Results First Posted: 2019-03-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified