NCT00400842

A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

A Double-blind, Placebo-controlled, Parallel-group, Comparative Study to Confirm the Safety and Efficacy of Oral 1.5 g/Day and 3.0 g/Day 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: 274 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	SA-001	0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
DRUG	SA-001	0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2006-11-17
• Last updated: 2011-07-28

Locations

98 sites across 1 country: Japan