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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00559364
• Date of registration: 14/11/2007
• Prospective Registration: No
• Primary sponsor: Forest Laboratories
• Public title: Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
• Scientific title: 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
• Date of first enrolment: November 2007
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00559364
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, Germany, Poland, Slovakia, United States

Contacts

• Name: Aptalis Medical Information
• Affiliation: Forest Laboratories

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient 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 prior to and during the study and must
agree not to attempt to become pregnant during the study; and 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 or partial or total resection of the pancreas

- Patients with CP due to alcohol abuse may be included provided they show no clinical
symptoms of recent alcohol consumption and no alcohol withdrawal symptoms

- Patients with CP must have at least one of the following conditions: an abnormal
secretin test, diffuse calcification of the pancreas on plain film of the abdomen, an
abnormal endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic
ultrasound, an abnormal computed tomography (CT) (dilated main pancreatic duct,
atrophy or calcification of the pancreas) or serum trypsin concentration below 20
nanogram per milliliter (ng/mL)

- Patients must have evidence of EPI as demonstrated by a fecal elastase (FE-1)
determination equal to or below 100 microgram/gram (mcg/g) of stools (FE-1 ScheBo
test) at screening

- Patients must have evidence of EPI as manifested by a CFA% below 80% after the
wash-out phase

- Patients must be able to comply with a high-fat diet

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Exocrine Pancreatic Insufficiency

Pancreatectomy

Intervention(s)

Drug: Proton pump inhibitor (PPI)

Drug: Viokase® 16

Drug: Placebo

Drug: Omeprazole

Primary Outcome(s)

Percent Coefficient of Fat Absorption (CFA) [Time Frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase]

Secondary Outcome(s)

Mean Daily Number of Stools [Time Frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase]

Percentage of Stools Categorized as Per Consistency [Time Frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase]

Secondary ID(s)

VIO16EPI07-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00559364