Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Exocrine Pancreatic Insufficiency: Cystic Fibrosis
Interventions
DRUG

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.

DRUG

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.

Trial Locations (37)

Unknown

University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA), Antwerp

Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose, Ghent

Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski, Pleven

Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi, Plovdiv

Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease, Rousse

Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina, Varna

Hôpital Arnaud de Villeneuve, Montpellier

Nouvel Hôpital Civil, Strasbourg

Ruhr-Universitaet Bochum - St. Josef Hospital, Bochum

Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Dresden

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitaetsklinikum Essen gGmbH, Essen

Universitätsklinikum Essen Zentrum f.Kinderheilkunde Klinik f.Kinderheilkunde III, Essen

Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin, Jena

Medizinische Klinik Innenstadt, München

Universitaetsklinik für Kinder- und Jugendmedizin Tuebingen, Tübingen

Azienda Ospedaliero Universitaria, Ospedali Riuniti, Ospedale Pediatrico G. Salesi, Ancona

Azienda Ospedale Policlinico di Bari, Bari

University of Catania, Catania

Azienda Ospedaliera Universitaria Policlinico G. Martino, Gastroenterologia Pediatrica E Fibrosi Cistica, Contesse -Messina

University Federico II of Naples, Pediatrics Department, Naples

Clinica di Malattie dell'Apparato Respiratorio, Orbassano (Torino)

Istituto Azienda Ospedaliera Universitaria, Parma

Universita degli Studi di Roma La Sapienza, Azienda Policlinico Umberto I, Dipartimento di Pediatria, Centro Fibrosi Cistica Regione Lazio, Roma

Bambino Gesu Hospital, Cystic Fibrosis Unit, Rome

Ospedale Infantile Regina Margherita, Turin

Azienda Ospedaliera Universitaria Integrata, Centro Fibrosi Cistica-Ospedale Civile Maggiore, Verona

Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem Poradnia Leczenia Mukowiscydozy, Gdansk

Centrum Pulmonologii i Alergologii w Karpaczu, Karpacz

Wojewodzki Szpital Specjalistyczny im Kopernika, Lodz

ALERGOTEST s.c Specjalistyczne Centrum Medyczne, Lublin

Szpital Kliniczny im Karola Jonschera, Poznan

NZOZ Sanatorium Cassia Villa Medica, Rabka-Zdrój

NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii, Rzeszów

Centrum Zdrowia Matki, Dziecka i Mlodziezy, Warsaw

IRMED Irena Wojciechowska, Warsaw

Liverpool Heart and Chest Hospital, Liverpool

Sheffield Children's Hospital, The Academic Unit of Child Health, Sheffield

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY