Status:
COMPLETED
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
Lead Sponsor:
Abbott
Conditions:
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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 patien...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00401076
Start Date
July 1 2008
End Date
September 1 2010
Last Update
August 1 2011
Active Locations (17)
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1
Site Reference ID/Investigator# 45211
Fukuoka, Japan
2
Site Reference ID/Investigator# 45297
Fukuoka, Japan
3
Site Reference ID/Investigator# 45220
Hiroshima, Japan
4
Site Reference ID/Investigator# 45279
Hiroshima, Japan