A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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 compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

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