Clinical Trial: A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Exo
Brief 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.
Detailed Summary:
Sponsor: Abbott
Current Primary Outcome: Change in CFA from baseline to the end of double-blind treatment [ Time Frame: 7 days after baseline ]
Original Primary Outcome: Change in Coefficient of Fat Absorption
Current Secondary Outcome: Stool fat excretion, stool weight, stool frequency, nutritional parameters [ Time Frame: 7 days after baseline ]
Original Secondary Outcome: Stool fat excretion, Stool weight, Stool frequency
Information By: Abbott
Dates:
Date Received: November 16, 2006
Date Started: May 2007
Date Completion:
Last Updated: July 27, 2011
Last Verified: July 2011