An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI).
Sponsor: AAIPharma
Listed as NCT00559052, this PHASE2 trial focuses on Exocrine Pancreatic Insufficiency and remains completed. Sponsored by AAIPharma, it has been updated 6 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Mar 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- AAIPharma
- Axcan Pharma
- City Hospital Laboratory Birmingham
- Mayo Clinical Services
For direct contact, visit the study record on ClinicalTrials.gov .