NCT00401076

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

A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy

Interventions

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

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2006-11-17
• Last updated: 2011-08-01

Locations

17 sites across 1 country: Japan