A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
Primary Purpose
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SA-001
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy focused on measuring SA-001, Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
Eligibility 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.
Sites / Locations
- Site Reference ID/Investigator# 45211
- Site Reference ID/Investigator# 45297
- Site Reference ID/Investigator# 45220
- Site Reference ID/Investigator# 45279
- Site Reference ID/Investigator# 45223
- Site Reference ID/Investigator# 45303
- Site Reference ID/Investigator# 45091
- Site Reference ID/Investigator# 45110
- Site Reference ID/Investigator# 45213
- Site Reference ID/Investigator# 45207
- Site Reference ID/Investigator# 45111
- Site Reference ID/Investigator# 45282
- Site Reference ID/Investigator# 45283
- Site Reference ID/Investigator# 45106
- Site Reference ID/Investigator# 45242
- Site Reference ID/Investigator# 45281
- Site Reference ID/Investigator# 45299
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00401076
Brief Title
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
Keywords
SA-001, Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SA-001
Intervention Description
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki Yamaguchi, BS Pharm
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 45211
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 45297
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 45220
City
Hiroshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 45279
City
Hiroshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 45223
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 45303
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 45091
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 45110
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 45213
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 45207
City
Kyoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 45111
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 45282
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 45283
City
Nagasaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 45106
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 45242
City
Sapporo
Country
Japan
Facility Name
Site Reference ID/Investigator# 45281
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 45299
City
Yamaguchi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
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