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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:
ClinicalTrials.gov Identifier:
NCT00401076
First Posted: November 17, 2006
Last Update Posted: August 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401076


Locations
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, Japan
Sponsors and Collaborators
Abbott
Investigators
Study Director: Toshiaki Yamaguchi, BS Pharm Abbott
  More Information

Responsible Party: Toshiaki Yamaguchi, Sr. Clinical Project Manager, Abbott
ClinicalTrials.gov Identifier: NCT00401076     History of Changes
Other Study ID Numbers: S245.3.123
First Submitted: November 16, 2006
First Posted: November 17, 2006
Last Update Posted: August 1, 2011
Last Verified: July 2011

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