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

Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
• Pancreatitis
• Pancreatitis, Chronic

• NCT number: NCT00401076
• Study type: Interventional
• Source: Abbott
• Status: Completed
• Phase: Phase 3
• Start date: July 2008
• Completion date: September 2010