NCT00559364

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a Phase III, multicenter, randomized, double-blind, parallel, placebo-controlled study, to assess the efficacy and safety of Viokase® 16 for the correction of steatorrhea in patients with EPI due to CP or pancreatectomy. The study will include the following phases: screening phase (up to 10 days), wash-out phase (6 to 7 days), randomization phase (up to 10 days), and treatment phase (6 to 7 days). In screening phase, patients will undergo screening procedures prior to entry into the study. In wash-out phase, stool collection will be performed to allow determination of the baseline CFA. In randomization phase, patients who qualify for the Treatment Phase (that is, patients who have a CFA% below 80%) will be randomized in the study. In the treatment phase, patients will be randomized in a 2:1 ratio (Viokase® 16 or Placebo). In treatment phase, stool collection period will be performed to allow determination of the CFA% that will serve to assess the efficacy of Viokase® 16 for the correction of steatorrhea. Follow-up procedures will be scheduled 7 to 10 days after discharge. Patients who do not show abnormal findings, adverse events or concomitant medications during the treatment phase will be assessed via follow-up telephone call. Patients who show abnormal findings (physical examination, vital signs, clinical laboratory tests, adverse events, concomitant medications) during the treatment phase will complete a follow-up visit.

Conditions

• Exocrine Pancreatic Insufficiency
• Chronic Pancreatitis
• Pancreatectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-11-16
• Last updated: 2017-03-16
• Results posted: 2014-03-12

Locations

18 sites across 4 countries: United States, Canada, Poland, Slovakia