Safety and Efficacy Study of VIOKASE 16 for the Correction of Steatorrhea
Information source: Axcan Pharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exocrine Pancreatic Insufficiency; Chronic Pancreatitis
Intervention: VIOKASE 16 (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Axcan Pharma Official(s) and/or principal investigator(s):
Phillip P. Toskes, MD, Principal Investigator, Affiliation: University of Florida
Overall contact:
Jean-Rene Basque, PhD, Phone: (450) 467-5138, Ext: 2164, Email: jrbasque@axcan.com
Summary
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.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Parelele,Placebo-Controlled, Phase-III Study to Assess the Safety and Efficacy of VIOAKSE16 for the Correction of Steatorrhrea in Patients With Exocrine Pancreatic Insufficiency
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy of VIOKASE 16 for the correction of steatorrhea (malabsorption of dietary fats). The efficacy will be based on a comparison of the Coefficient of Fecal Fat Absorption (CFA%) between VIOKASE 16 and placebo.
Secondary outcome: Effect of VIOKASE 16 on stool frequency and stool characteristics.
Evaluate the safety of VIOKASE 16 used for the correction of steatorrhea using laboratory analyses and adverse events.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
symptoms.
- 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
(CFA%).
Exclusion Criteria:
- 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
Pancreatitis.
- 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
hypertension.
- 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.
Locations and Contacts
Jean-Rene Basque, PhD, Phone: (450) 467-5138, Ext: 2164, Email: jrbasque@axcan.com
KKS-TU GmbH, Tubingen, Germany; Not yet recruiting
Medizinische Klinik und Poliklinik II, Leipzig, Germany; Not yet recruiting
Israelitisches Krankenhaus in Hamburg, Hamburg, Germany; Not yet recruiting
Klinikum der Ernst-Moritz-Arndt Universitat, Greifswald, Germany; Not yet recruiting
Otto-von-Guericke-Universitat Madgeburg, Magdeburg, Germany; Not yet recruiting
Charité Universitätsmedizin Berlin, Berlin, Germany; Not yet recruiting
Fakultät für Klinische Medizin, Mannheim, Germany; Not yet recruiting
Klinikum der Johann-Wolfgang-Goethe, Frankfurt, Germany; Not yet recruiting
SP Szpital Kliniczny nr 4 w Lublinie, Lublin, Poland; Not yet recruiting
Wojewodzki Szpital Specjalistyczny Nr5, Sosnowiec, Poland; Not yet recruiting
Samodzielny Publiczny Centralny, Katowice, Poland; Not yet recruiting
Wojewodzki Szpital Brodnowski, Warszawa, Poland; Not yet recruiting
Klinika Gastroenterologii i Chorób Przemiany Materii, Warszawa, Poland; Recruiting
Uniwersytecki Szpital Kliniczny nr 1 im, Lodz, Poland; Not yet recruiting
Akademicki Szpital Liniczny, Wroclaw, Poland; Recruiting
III Oddzial Chorób Wewnetrznych i Gastroenterologii, Bialystok, Poland; Recruiting
Klinika Chorob Wewnetrznych i Gastroenterologii, Warszawa, Poland; Recruiting
5 Wojskowy Szpital Kliniczny z Poliklinika, Klinika Chorob, Krakow, Poland; Not yet recruiting
Akademickie Centrum Kliniczne, Gdansk, Poland; Not yet recruiting
SP Szpital Kliniczny nr 1 Klinika Gastroenterologii, Szczecin, Poland; Not yet recruiting
Saint Louis University, Saint Louis, Missouri 63104, United States; Not yet recruiting
Frank R. Burton, MD
Nancy Denney, RN
Darmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Stuart R. Gordon, MD
Carol Moriarty, RN
Hotel-Dieu de Levis, Levis, Quebec G6V 3Z1, Canada; Not yet recruiting
Raymond Bourdages, MD
Marie Berberi, RN
Additional Information
Starting date: November 2007
Ending date: March 2008
Last updated: November 19, 2007
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