A phase III study of FPF3401

Phase 3

• Conditions: Hyposelenemia

• Registration Number: JPRN-jRCT2031220210
• Lead Sponsor: rabe Hiromi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Previously untreated patients
1)Patients with hyposelenemia or suspected hyposelenemia.
2)Patients having capability of intestinal absorption of selenium.
3)Patients on enteral nutrition therapy or diet therapy.
4)Patients with serum selenium concentrations below the reference value.

High-dose treatment patients
1)Patients with hyposelenemia or suspected hyposelenemia.
2)Patients daily treated with high-dose selenium preparations by oral or tube administration.
3)Patients having capability of intestinal absorption of selenium.

Exclusion Criteria

Previously untreated patients
1)Patients mainly treated with their nutrition intravenously.
2)Patients treated with any of the following drugs.
(1)Selenium preparations
(2)Teduglutide
3)Patients allergic to selenium.

High-dose treatment patients
1)Patients treated with any of the following drugs.
(1)Selenium preparations (except for oral or tube administration)
(2)Teduglutide
2)Patients allergic to selenium.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A rate of cases with serum selenium concentrations reaching and being maintained at the reference interval.

Secondary Outcome Measures

Name	Time	Method
Safety etc.