Status:
COMPLETED
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
Lead Sponsor:
Abbott
Conditions:
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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 comp...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects with chronic pancreatitis in the non-compensatory stage or pancreatectomy
- Subjects whose CFA is 80% or less
- Subjects who are able to be hospitalized
- Exclusion Criteria
- Subjects who are judged to be difficult to have at least 40 g/day of fat intake during course of the study
- Subjects who have a known allergy to porcine protein and/or any component of digestive enzyme preparations
- Subjects who are in the acute phase of chronic pancreatitis
- Subjects with non-pancreatic malabsorption syndrome
- Subjects with acute pancreatitis or ileus
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00400842
Start Date
May 1 2007
End Date
August 1 2009
Last Update
July 28 2011
Active Locations (98)
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1
Site Reference ID/Investigator# 59845
Aichi, Japan
2
Site Reference ID/Investigator# 59933
Aichi, Japan
3
Site Reference ID/Investigator# 59928
Akita, Japan
4
Site Reference ID/Investigator# 59983
Amori, Japan