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

Phase 1

• Conditions: Correction of steatorrhea (malabsorption of dietary fats) in patients with exocrine pancreatic insufficiency; MedDRA version: 9.1Level: PTClassification code 10033628Term: Pancreatic insufficiency

• Registration Number: EUCTR2007-000342-12-SK
• Lead Sponsor: Axcan Pharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-18
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients will be eligible for inclusion in this study only if all of the following criteria apply:
-Patients must be male or female, aged 18-80 years.
-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 (hormonal, long-term injectable, implantable, transdermal contraceptives or double-barrier method) prior to and during the study and must agree not to attempt to become pregnant during the study. Female patients of non-childbearing potential must be surgically sterile or postmenopausal for at least 12 consecutive months.
-Patients must have a medical condition compatible with EPI such as Chronic Pancreatitis and partial or total resection of the pancreas.
-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 symptoms.
-Patients with Chronic Pancreatitis must have at least one of the following:
•an abnormal secretin test,
•diffuse calcification of the pancreas on plain film of the abdomen,
•an abnormal ERCP or endoscopic ultrasound
•an abnormal CT (dilated main pancreatic duct, atrophy or calcification of the pancreas)
•a serum trypsin concentration below 20ng/mL
-Patients must have evidence of EPI as demonstrated by a fecal Elastase below 100µg/g of stools (FE-1 ScheBo test) at screening.
-Patients must have evidence of EPI as manifested by a Coefficient of Fat Absorption (CFA%) below 80% (< 80%) after the Wash-Out phase.
-Patients must be able to comply with a high-fat diet.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study:

-Patients with a known hypersensitivity and/or contraindication to VIOKASE® 16 or any protein of porcine origin.
-Patients with acute pancreatitis or with an acute exacerbation of Chronic Pancreatitis at screening or within the last two 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 (i.e. Body Mass Index < 18).
-Patients not willing to stop, at wash-out phase and throughout the treatment phase, medications or products that could interfere with fecal fat excretion (e.g. laxatives, enzyme supplements, motility drugs, etc.).
-Patients who do not limit alcohol intake to less than or equal to one (1) drink per day during Screening and Randomization Phases and patients who do not refrain from drinking during Inpatient Periods of the study (i.e., stool collections).
-Patients who have been treated with the following drugs within 7 days prior to screening: H2-receptor antagonists, GI 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 with a known allergy to the FD&C Blue No. 2 dye indicator (stool marker).
-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 AST or ALT levels greater than three times the upper limit of normal values or elevated uric acid levels greater than 1.5 times the upper limit of normal values
-Causes for EPI other than Chronic Pancreatitis and partial/total pancreas resection, e.g., 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 cardiovascular 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. The same applies for immunocompromised patients and/or neutropenic patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified