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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401076
• Other study ID #: S245.3.123
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2006
• Last updated: July 28, 2011
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding discontinued subjects).

Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced adverse drug reactions in the S245.3.122 clinical study.

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

Intervention

Drug:
• SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 45211	Fukuoka
Japan	Site Reference ID/Investigator# 45297	Fukuoka
Japan	Site Reference ID/Investigator# 45220	Hiroshima
Japan	Site Reference ID/Investigator# 45279	Hiroshima
Japan	Site Reference ID/Investigator# 45223	Hokkaido
Japan	Site Reference ID/Investigator# 45303	Hokkaido
Japan	Site Reference ID/Investigator# 45091	Hyogo
Japan	Site Reference ID/Investigator# 45110	Kanagawa
Japan	Site Reference ID/Investigator# 45213	Kanagawa
Japan	Site Reference ID/Investigator# 45207	Kyoto
Japan	Site Reference ID/Investigator# 45111	Miyagi
Japan	Site Reference ID/Investigator# 45282	Miyagi
Japan	Site Reference ID/Investigator# 45283	Nagasaki
Japan	Site Reference ID/Investigator# 45106	Osaka
Japan	Site Reference ID/Investigator# 45242	Sapporo
Japan	Site Reference ID/Investigator# 45281	Tokyo
Japan	Site Reference ID/Investigator# 45299	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No