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

Exclusion Criteria

• •Patients with a known hypersensitivity and/or contraindication to any of the study medications, to their excipients, components or to Federal Food, Drug, and Cosmetic (FD and C) Blue No. 2 dye marker
• •Patients with acute pancreatitis or with an acute exacerbation of CP at screening or within the last 2 weeks before screening
• •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 (body mass index less than 18)
• •Patient not willing to be off therapeutic doses for at least 7 days prior to study entry and throughout the course of the study, medications or products that could interfere with fecal fat excretion
• •Patients who do not limit alcohol intake to less than or equal to 1 drink per day during screening and randomization phases and patients who do not refrain from drinking during inpatient periods of the study
• •Patients who have been treated with the following drugs within 7 days prior to screening: H2-receptor antagonists, gastrointestinal anticholinergics and antispasmodics
• •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 hypertension
• •Patients who have a condition known to increase fecal fat loss including celiac disease, biliary cancer, biliary stricture, cholelithiasis, Crohn's disease, pancreatic cancer, radiation enteritis, tropical sprue, whipple's disease, lactose intolerance, pseudomembranous colitis
• •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
• •Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal values or elevated uric acid levels greater than 1.5 times the upper limit of normal values
• •Patients with causes for EPI other than CP and partial/total pancreas resection, example, cystic fibrosis, primary sclerosing cholangitis, hemochromatosis, isolated enzyme deficiency, deficiency in activation of enzymes in the small intestine etc
• •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, which, in the opinion of the investigator, would pose a significant risk for the patient, invalidate the giving of informed consent or limit the ability of the patients to comply with study requirements or interfere otherwise with the conduct of the study and the same applies for immunocompromised patients and/or neutropenic patients