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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014