A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
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
1 other identifier
interventional
80
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2008
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2006
CompletedFirst Posted
Study publicly available on registry
November 17, 2006
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedAugust 1, 2011
July 1, 2011
2.2 years
November 16, 2006
July 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (17)
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
Hyōgo, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toshiaki Yamaguchi, BS Pharm
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 16, 2006
First Posted
November 17, 2006
Study Start
July 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
August 1, 2011
Record last verified: 2011-07