deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT00559052

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

Interventions VIOKASE 16
Updated 6 times since 2017 Last updated: Feb 9, 2010 Started: Mar 31, 2008 Primary completion: Feb 28, 2009 Completion: Feb 28, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

Show 1 earlier version
  1. 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

Sponsor contact:
  • AAIPharma
  • Axcan Pharma
  • City Hospital Laboratory Birmingham
  • Mayo Clinical Services
Data source: Axcan Pharma

For direct contact, visit the study record on ClinicalTrials.gov .