A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency

Abbott80 enrolled

Overview

This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy

Interventions

SA-001DRUG

0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding discontinued subjects). Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced adverse drug reactions in the S245.3.122 clinical study.

Locations (17)

Site Reference ID/Investigator# 45211

Fukuoka, Japan

Site Reference ID/Investigator# 45297

Fukuoka, Japan

Site Reference ID/Investigator# 45220

Outcomes

Primary Outcomes

Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)

Time frame: 52 weeks

Secondary Outcomes

Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)

Time frame: 52 weeks

Data from ClinicalTrials.gov

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