Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.
NCT ID: NCT01641393
Last Updated: 2014-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
96 participants
INTERVENTIONAL
2012-06-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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EUR-1008 then Kreon
* EUR-1008 during Treatment Period 1 (29 days ±2 days) and
* Kreon during Treatment Period 2 (29 days ±2 days).
EUR-1008 25,000 Units
EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18 Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity. Each capsule contains approximately 25,000 Ph. Eur. lipase units. EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.
Kreon 25,000 Units
Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18 Each capsule contains approximately 25,000 Ph. Eur. lipase units. Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.
Kreon then EUR-1008
* Kreon during Treatment Period 1 (29 days ±2 days) and
* EUR-1008 during Treatment Period 2 (29 days ±2 days).
EUR-1008 25,000 Units
EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18 Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity. Each capsule contains approximately 25,000 Ph. Eur. lipase units. EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.
Kreon 25,000 Units
Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18 Each capsule contains approximately 25,000 Ph. Eur. lipase units. Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.
Interventions
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EUR-1008 25,000 Units
EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18 Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity. Each capsule contains approximately 25,000 Ph. Eur. lipase units. EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.
Kreon 25,000 Units
Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18 Each capsule contains approximately 25,000 Ph. Eur. lipase units. Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One clinical feature consistent with CF and
* Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration \>60 mEq/L by pilocarpine iontophoresis
2. Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 μg/g stool at screening (test results within the previous 12 months are acceptable)
3. Currently receiving pancreatic enzyme replacement therapy
4. Adequate nutritional status based on the following: body mass index (BMI) \>19 kg/m2 in adult subjects or a BMI percentile 10th percentile for age in adolescent (12 to 17 years age group) subjects
5. Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study
Exclusion Criteria
2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs
3. Current uncontrolled diabetes mellitus
4. History of solid organ transplantation
5. History of surgery affecting the bowel function and weight gain
12 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Taylor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sheffield Children's Hospital, The Academic Unit of Child Health
Locations
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University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, , Belgium
Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose
Ghent, , Belgium
Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski
Pleven, , Bulgaria
Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi
Plovdiv, , Bulgaria
Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease
Rousse, , Bulgaria
Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina
Varna, , Bulgaria
Hôpital Arnaud de Villeneuve
Montpellier, , France
Nouvel Hôpital Civil
Strasbourg, , France
Ruhr-Universitaet Bochum - St. Josef Hospital
Bochum, , Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitaetsklinikum Essen gGmbH
Essen, , Germany
Universitätsklinikum Essen Zentrum f.Kinderheilkunde Klinik f.Kinderheilkunde III
Essen, , Germany
Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin
Jena, , Germany
Medizinische Klinik Innenstadt
München, , Germany
Universitaetsklinik für Kinder- und Jugendmedizin Tuebingen
Tübingen, , Germany
Azienda Ospedaliero Universitaria, Ospedali Riuniti, Ospedale Pediatrico G. Salesi
Ancona, , Italy
Azienda Ospedale Policlinico di Bari
Bari, , Italy
University of Catania
Catania, , Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino, Gastroenterologia Pediatrica E Fibrosi Cistica
Contesse -Messina, , Italy
University Federico II of Naples, Pediatrics Department
Naples, , Italy
Clinica di Malattie dell'Apparato Respiratorio
Orbassano (Torino), , Italy
Istituto Azienda Ospedaliera Universitaria
Parma, , Italy
Universita degli Studi di Roma La Sapienza, Azienda Policlinico Umberto I, Dipartimento di Pediatria, Centro Fibrosi Cistica Regione Lazio
Roma, , Italy
Bambino Gesu Hospital, Cystic Fibrosis Unit
Rome, , Italy
Ospedale Infantile Regina Margherita
Turin, , Italy
Azienda Ospedaliera Universitaria Integrata, Centro Fibrosi Cistica-Ospedale Civile Maggiore
Verona, , Italy
Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem Poradnia Leczenia Mukowiscydozy
Gdansk, , Poland
Centrum Pulmonologii i Alergologii w Karpaczu
Karpacz, , Poland
Wojewodzki Szpital Specjalistyczny im Kopernika
Lodz, , Poland
ALERGOTEST s.c Specjalistyczne Centrum Medyczne
Lublin, , Poland
Szpital Kliniczny im Karola Jonschera
Poznan, , Poland
NZOZ Sanatorium Cassia Villa Medica
Rabka-Zdrój, , Poland
NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii
Rzeszów, , Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, , Poland
IRMED Irena Wojciechowska
Warsaw, , Poland
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Sheffield Children's Hospital, The Academic Unit of Child Health
Sheffield, , United Kingdom
Countries
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References
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Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
Taylor CJ, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21.
Other Identifiers
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2009-012842-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PR-005
Identifier Type: -
Identifier Source: org_study_id
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