Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00559364 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT00559364: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00559364 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00559364, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study Summary
This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly Axcan).
Primary Outcome
Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined in the stools which was collected from Day 1 to Day 4 or Day 5 during the inpatient period of treatment phase. Mean percent (%) CFA was calculated for Day 1 to Day 4 or Day 5 in inpatient period of treatment phase.
Interventions
- DRUG Placebo
- DRUG Omeprazole
- DRUG Proton pump inhibitor (PPI)
- DRUG Viokase® 16
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00559364 record still lists
NCT00559364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00559364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00559364 about?
NCT00559364 is a clinical study titled "Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea". This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly A...
What is the current status of trial NCT00559364?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2007-11. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00559364?
The interventions under investigation include: Placebo (DRUG), Omeprazole (DRUG), Proton pump inhibitor (PPI) (DRUG), Viokase® 16 (DRUG).
Who is sponsoring clinical trial NCT00559364?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00559364's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia