Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
Condition: Exocrine Pancreatic Insufficiency; Chronic Pancreatitis; Pancreatectomy
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency; Steatorrhea
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Viokase® 16; Placebo; Proton pump inhibitor (PPI); Omeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; Patients on PPI during Screening will continue their usual PPI therapy throughout the study.; Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.
Intervention MeSH terms: Omeprazole; Pancrelipase; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment