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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00401076
First received: November 16, 2006
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
Drug: SA-001
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401076

Locations
Japan
Site Reference ID/Investigator# 45297
Fukuoka, Japan
Site Reference ID/Investigator# 45211
Fukuoka, Japan
Site Reference ID/Investigator# 45279
Hiroshima, Japan
Site Reference ID/Investigator# 45220
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# 45213
Kanagawa, Japan
Site Reference ID/Investigator# 45110
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, Japan
Sponsors and Collaborators
Abbott
Investigators
Study Director: Toshiaki Yamaguchi, BS Pharm Abbott
  More Information

No publications provided

Responsible Party: Toshiaki Yamaguchi, Sr. Clinical Project Manager, Abbott
ClinicalTrials.gov Identifier: NCT00401076     History of Changes
Other Study ID Numbers: S245.3.123
Study First Received: November 16, 2006
Last Updated: July 28, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
SA-001
Pancreatic Exocrine Insufficiency
Chronic Pancreatitis
Pancreatectomy

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014