This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
274
Change in CFA from baseline to the end of double-blind treatment
Time frame: 7 days after baseline
Stool fat excretion, stool weight, stool frequency, nutritional parameters
Time frame: 7 days after baseline
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Site Reference ID/Investigator# 59845
Aichi, Japan
Site Reference ID/Investigator# 59933
Aichi, Japan
Site Reference ID/Investigator# 59928
Akita, Japan
Site Reference ID/Investigator# 59983
Amori, Japan
Site Reference ID/Investigator# 59984
Amori, Japan
Site Reference ID/Investigator# 59569
Ehime, Japan
Site Reference ID/Investigator# 59938
Ehime, Japan
Site Reference ID/Investigator# 59571
Fukuoka, Japan
Site Reference ID/Investigator# 59572
Fukuoka, Japan
Site Reference ID/Investigator# 59812
Fukuoka, Japan
...and 88 more locations