Exocrine pancreatic insufficiency (EPI) leading to maldigestion is a frequent finding in
many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most
important digestive malfunction in EPI. Frequently, lipid malabsorption develops earlier
than malabsorption of other nutrients. The current treatment of EPI includes enzyme
supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase,
amylase and protease. The planned clinical study should contribute to confirming the
clinical efficacy and safety of VIOKASE 16 tablets compared to placebo in patients with
exocrine pancreatic insufficiency by means of the stool fat content test.
The study will include the following phases: the Screening Phase, the Wash-Out Phase, the
Randomization Phase, and the Treatment Phase
Screening Phase: Patients will undergo screening procedures prior to entry into the study.
Wash-Out Phase: Stool collection will be performed to allow determination of the baseline
Coefficient of Fat Absorption (CFA%).
Randomization Phase: Patients who meet inclusion and exclusion criteria will be randomized
in the study.
Treatment Phase: Stool collection period will be performed to allow determination of the
Coefficient of Fat Absorption* (CFA%) that will serve to assess the efficacy of VIOKASE 16
for the correction of steatorrhea.
- Patients must have the ability to provide Informed Consent.
- Female patients of childbearing potential must have a negative pregnancy test at
Screening, must use adequate contraception.
- Patients must have a medical condition compatible with EPI.
- Patients with Chronic Pancreatitis due to alcohol abuse may be included provided they
show no clinical symptoms of recent alcohol consumption and no alcohol withdrawal
- Patients with Chronic Pancreatitis.
- Patients must have evidence of EPI as demonstrated by a fecal Elastase determination.
- Patients must have evidence of EPI as manifested by a Coefficient of Fat Absorption
- Patients with a known hypersensitivity and/or contraindication to any of the study
medications, to their excipients or to their components.
- Patients with acute pancreatitis or with an acute exacerbation of Chronic
- Patients with any active or recurrent malignant pancreatic tumor.
- Patients with a history of significant bowel resection.
- Patients with a dysmotility disorder.
- Patients with insufficient body mass (i.e. Body Mass Index < 18).
- Patients known to have a significant medical and/or mental disease that would
compromise the patient's welfare or confound the study results.
- Patients with a history of fibrosing colonopathy, cirrhosis of the liver, or portal
- Patients with a known allergy to the FD&C Blue No. 2 dye marker.
- Patients who have a condition known to increase fecal fat loss.
- Female patients who are pregnant or breastfeeding.
- Patients who have received an Investigational drug within 30 days prior to entering
the screening phase of the study.
- Causes for EPI other than Chronic Pancreatitis and partial/total pancreas resection.
- Patients with a history or clinical evidence of any relevant cardio- or
cerebrovascular, renal, endocrine, neurologic, infectious, other gastrointestinal,
hematological, oncological or psychiatric disease or emotional problems.