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

Phase 3

Completed

• Conditions: Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
• Interventions: Drug: SA-001

• Registration Number: NCT00401076
• Lead Sponsor: Abbott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Study Start: 2008-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-28
• Last Update Posted: 2011-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SA-001	-

Primary Outcome Measures

Name	Time	Method
Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)	52 weeks

Trial Locations

Locations (17)

Site Reference ID/Investigator# 45220; 🇯🇵 Hiroshima, Japan

Site Reference ID/Investigator# 45213; 🇯🇵 Kanagawa, Japan

Site Reference ID/Investigator# 45282; 🇯🇵 Miyagi, Japan

Site Reference ID/Investigator# 45106; 🇯🇵 Osaka, Japan

Site Reference ID/Investigator# 45297; 🇯🇵 Fukuoka, Japan

Site Reference ID/Investigator# 45223; 🇯🇵 Hokkaido, Japan

Site Reference ID/Investigator# 45211; 🇯🇵 Fukuoka, Japan

Site Reference ID/Investigator# 45110; 🇯🇵 Kanagawa, Japan

Site Reference ID/Investigator# 45111; 🇯🇵 Miyagi, Japan

Site Reference ID/Investigator# 45281; 🇯🇵 Tokyo, Japan

Site Reference ID/Investigator# 45279; 🇯🇵 Hiroshima, Japan

Site Reference ID/Investigator# 45303; 🇯🇵 Hokkaido, Japan

Site Reference ID/Investigator# 45299; 🇯🇵 Yamaguchi, Japan

Site Reference ID/Investigator# 45283; 🇯🇵 Nagasaki, Japan

Site Reference ID/Investigator# 45091; 🇯🇵 Hyogo, Japan

Site Reference ID/Investigator# 45207; 🇯🇵 Kyoto, Japan

Site Reference ID/Investigator# 45242; 🇯🇵 Sapporo, Japan