NCT00559364 is a Phase 3 clinical trial of Viokase® 16 in Exocrine Pancreatic Insufficiency, sponsored by Forest Laboratories.

Who is sponsoring NCT00559364?

NCT00559364 is sponsored by Forest Laboratories.

What drugs are being tested in NCT00559364?

Interventions in NCT00559364: Viokase® 16, Placebo, Proton pump inhibitor (PPI), Omeprazole.

What condition does NCT00559364 study?

NCT00559364 studies Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy.

Is NCT00559364 still recruiting?

NCT00559364 is currently completed. Last updated 7 February 2017.

Are results published for NCT00559364?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-02-07 · How we verify

NCT00559364

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency

Completed Phase 3 Results posted Last updated 7 February 2017

What this trial tests

Phase 3 trial testing Viokase® 16 in Exocrine Pancreatic Insufficiency in 50 participants. Completed in 1 July 2009.

Timeline

1 November 2007

Primary endpoint
1 July 2009

1 July 2009

Quick facts

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 November 2007
Primary completion	1 July 2009
Estimated completion	1 July 2009
Sites	18 locations across United States, Canada, Poland, Slovakia

Drugs / interventions tested

Viokase® 16
Placebo
Proton pump inhibitor (PPI) — full drug profile →
Omeprazole (omeprazole) — full drug profile →

Conditions studied

Exocrine Pancreatic Insufficiency — all drugs for Exocrine Pancreatic Insufficiency →
Chronic Pancreatitis — all drugs for Chronic Pancreatitis →
Pancreatectomy — all drugs for Pancreatectomy →

Sponsor

Forest Laboratories — full company profile →

Who can join

Adults 18 to 80, any sex, with Exocrine Pancreatic Insufficiency or Chronic Pancreatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percent Coefficient of Fat Absorption (CFA)
Time frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase
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.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Exocrine Pancreatic Insufficiency

Currently open trials in the same condition.

NCT05710315 — Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure · NA · recruiting
NCT06477159 — Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency · Phase 4 · recruiting
NCT05112328 — The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding · NA · recruiting

Other Forest Laboratories trials

Trials by the same sponsor.

NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage · completed
NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer · Phase 2 · terminated
NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode · Phase 3 · completed
NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres · Phase 3 · completed
NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00559364 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forest Laboratories
Last refreshed: 7 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00559364.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing