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Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

NCT00559364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-03-16

Study results available
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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).

Conditions

  • Exocrine Pancreatic Insufficiency
  • Chronic Pancreatitis
  • Pancreatectomy

Interventions

DRUG

Viokase® 16

Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.

DRUG

Placebo

Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.

DRUG

Proton pump inhibitor (PPI)

Patients on PPI during Screening will continue their usual PPI therapy throughout the study.

DRUG

Omeprazole

Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Aptalis Medical Information · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States
  • Canada
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559364 on ClinicalTrials.gov