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Safety and Efficacy Study of VIOKASE 16 for the Correction of Steatorrhea
This study is currently recruiting participants.
Verified by Axcan Pharma, November 2007
First Received: November 14, 2007   Last Updated: November 19, 2007   History of Changes
Sponsor: Axcan Pharma
Collaborators: i3 Statprobe
Quintiles
Mayo Clinical Trial Services
Laboratoire Marcel Merieux
City Hospital Laboratory Birmingham
Information provided by: Axcan Pharma
ClinicalTrials.gov Identifier: NCT00559364
  Purpose

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.


Condition Intervention Phase
Exocrine Pancreatic Insufficiency
Chronic Pancreatitis
Drug: VIOKASE 16
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 4 months ]

Estimated Enrollment: 60
Study Start Date: November 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
1: Active Comparator
Arm A: VIOKASE 16
Drug: VIOKASE 16
The VIOKASE 16 is to be taken as 6 tablets with each meal and 2 tablets with two of three snacks for a total of 22 tablets per day.
2: Placebo Comparator
Arm B: Placebo
Drug: Placebo
The Placebo is to be taken as 6 tablets with each meal and 2 tablets with two of three snacks for a total of 22 tablets per day.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559364

Contacts
Contact: Jean-Rene Basque, PhD (450) 467-5138 ext 2164 jrbasque@axcan.com
Contact: Jean Spenard, PhD (450) 467-5138 ext 2184 jspenard@axcan.com

Locations
United States, Missouri
Saint Louis University Not yet recruiting
Saint Louis, Missouri, United States, 63104
Contact: Frank R. Burton, MD            
Contact: Nancy Denney, RN            
United States, New Hampshire
Darmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Stuart R. Gordon, MD            
Contact: Carol Moriarty, RN            
Canada, Quebec
Hotel-Dieu de Levis Not yet recruiting
Levis, Quebec, Canada, G6V 3Z1
Contact: Raymond Bourdages, MD            
Contact: Marie Berberi, RN            
Germany
KKS-TU GmbH Not yet recruiting
Tubingen, Germany
Medizinische Klinik und Poliklinik II Not yet recruiting
Leipzig, Germany
Klinikum der Johann-Wolfgang-Goethe Not yet recruiting
Frankfurt, Germany
Klinikum der Ernst-Moritz-Arndt Universitat Not yet recruiting
Greifswald, Germany
Otto-von-Guericke-Universitat Madgeburg Not yet recruiting
Magdeburg, Germany
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany
Fakultät für Klinische Medizin Not yet recruiting
Mannheim, Germany
Israelitisches Krankenhaus in Hamburg Not yet recruiting
Hamburg, Germany
Poland
SP Szpital Kliniczny nr 1 Klinika Gastroenterologii Not yet recruiting
Szczecin, Poland
Wojewodzki Szpital Specjalistyczny Nr5 Not yet recruiting
Sosnowiec, Poland
Samodzielny Publiczny Centralny Not yet recruiting
Katowice, Poland
Wojewodzki Szpital Brodnowski Not yet recruiting
Warszawa, Poland
Klinika Gastroenterologii i Chorób Przemiany Materii Recruiting
Warszawa, Poland
Uniwersytecki Szpital Kliniczny nr 1 im Not yet recruiting
Lodz, Poland
Akademicki Szpital Liniczny Recruiting
Wroclaw, Poland
III Oddzial Chorób Wewnetrznych i Gastroenterologii Recruiting
Bialystok, Poland
Klinika Chorob Wewnetrznych i Gastroenterologii Recruiting
Warszawa, Poland
5 Wojskowy Szpital Kliniczny z Poliklinika, Klinika Chorob Not yet recruiting
Krakow, Poland
Akademickie Centrum Kliniczne Not yet recruiting
Gdansk, Poland
SP Szpital Kliniczny nr 4 w Lublinie Not yet recruiting
Lublin, Poland
Sponsors and Collaborators
Axcan Pharma
i3 Statprobe
Quintiles
Mayo Clinical Trial Services
Laboratoire Marcel Merieux
City Hospital Laboratory Birmingham
Investigators
Principal Investigator: Phillip P. Toskes, MD University of Florida
  More Information

No publications provided

Study ID Numbers: VIO16EPI07-01
Study First Received: November 14, 2007
Last Updated: November 19, 2007
ClinicalTrials.gov Identifier: NCT00559364     History of Changes
Health Authority: United States: Institutional Review Board;   Germany: Federal Institute for Drugs and Medical Devices;   Canada: Health Canada;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Agents
Pancreatic Diseases
Pancrelipase
Pharmacologic Actions
Pancreatitis
Exocrine Pancreatic Insufficiency
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on February 08, 2010