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 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 50 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

Interventions

  • DRUG Placebo
  • DRUG Omeprazole
  • DRUG Proton pump inhibitor (PPI)
  • DRUG Viokase® 16

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2007-11
Est. Completion 2009-07
Phase Phase 3

Sponsor

Forest Laboratories

145 total trials

What the Registry Record Tells You About NCT00559364

The ClinicalTrials.gov registry entry for NCT00559364 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00559364 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.