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

Study Identifier
S245.3.123
CT.gov Identifier
NCT00401076
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Liver, Pancreas & Gallbladder - Other
    • Study Drug
  • SA-001
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 45211
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45297
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45220
    Hiroshima, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45279
    Hiroshima, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45223
    Hokkaido, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 45303
    Hokkaido, Japan
    Status
    Not applicable
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