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

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
Interventions
DRUG

SA-001

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

Trial Locations (17)

Unknown

Site Reference ID/Investigator# 45211, Fukuoka

Site Reference ID/Investigator# 45297, Fukuoka

Site Reference ID/Investigator# 45220, Hiroshima

Site Reference ID/Investigator# 45279, Hiroshima

Site Reference ID/Investigator# 45223, Hokkaido

Site Reference ID/Investigator# 45303, Hokkaido

Site Reference ID/Investigator# 45091, Hyōgo

Site Reference ID/Investigator# 45110, Kanagawa

Site Reference ID/Investigator# 45213, Kanagawa

Site Reference ID/Investigator# 45207, Kyoto

Site Reference ID/Investigator# 45111, Miyagi

Site Reference ID/Investigator# 45282, Miyagi

Site Reference ID/Investigator# 45283, Nagasaki

Site Reference ID/Investigator# 45106, Osaka

Site Reference ID/Investigator# 45242, Sapporo

Site Reference ID/Investigator# 45281, Tokyo

Site Reference ID/Investigator# 45299, Yamaguchi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY