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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.

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

Details

• Lead Sponsor: Abbott

Criteria

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.