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| 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 |
| 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.
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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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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 | |
| Principal Investigator: | Phillip P. Toskes, MD | University of Florida |
More Information
| 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 |
|
Digestive System Diseases Therapeutic Uses Gastrointestinal Agents Pancreatic Diseases Pancrelipase |
Pharmacologic Actions Pancreatitis Exocrine Pancreatic Insufficiency Pancreatitis, Chronic |