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Safety and Efficacy Study of VIOKASE 16 for the Correction of Steatorrhea

This study has been completed.
Sponsor:
Collaborators:
i3 Statprobe
Quintiles
Mayo Clinical Trial Services
Laboratoire Marcel Merieux
City Hospital Laboratory Birmingham
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00559364
First received: November 14, 2007
Last updated: May 4, 2010
Last verified: May 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:

U.S. FDA Resources

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
Study Completion Date: August 2009
Arms Assigned Interventions
Active Comparator: 1
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.
Placebo Comparator: 2
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

Locations
United States, New Hampshire
Darmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Canada, Quebec
Hotel-Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Poland
III Oddzial Chorób Wewnetrznych i Gastroenterologii
Bialystok, Poland, 15 950
Akademickie Centrum Kliniczne
Gdansk, Poland, 80 952
Samodzielny Publiczny Centralny
Katowice, Poland, 40 752
Klinika Chorob Wewnetrznych z Poliklinika
Krakow, Poland, 30 901
Uniwersytecki Szpital Kliniczny nr 1 im
Lodz, Poland, 90 153
SP Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland, 20 954
Wojewodzki Szpital Specjalistyczny Nr5
Sosnowiec, Poland, 40 200
SP Szpital Kliniczny nr 1 Klinika Gastroenterologii
Szczecin, Poland, 71 252
Wojewodzki Szpital Brodnowski
Warszawa, Poland, 03 242
Klinika Gastroenterologii i Chorób Przemiany Materii
Warszawa, Poland, 02 097
Klinika Chorob Wewnetrznych i Gastroenterologii
Warszawa, Poland, 02 507
Katedra Klinika Gastroenterologii
Wroclaw, Poland, 50 376
Slovakia
University Hospital Brastislava
Brastislava, Slovakia, 851 07
University Hospital Bratislava
Bratilslava, Slovakia, 826 06
NZZ Management spol.S.r.o.
Nitra, Slovakia, 949 01
Gastro I. s.r.o., Gastroenterologicka
Presov, Slovakia, 080 01
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

ClinicalTrials.gov Identifier: NCT00559364     History of Changes
Other Study ID Numbers: VIO16EPI07-01
Study First Received: November 14, 2007
Last Updated: May 4, 2010
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:
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
 Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013