87
Participants
Start Date
April 30, 2011
Primary Completion Date
May 31, 2012
Study Completion Date
May 31, 2012
Panzytrat® 25,000
Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period.
Kreon® 25,000
Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.
Klinikum-Bochum, Bochum
Universitätsklinikum Carl Gustav Carus, Dresden
Universitaetsklinikum Erlangen, Erlangen
Jena University Hospital, Universitaetsklinikum Jena, Jena
Klinikum der Universitat Munchen Medizinische Klinik-Innenstadt, München
University Children's Clinic Tubingen, Tübingen
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem Poradnia Leczenia Mukowiscydozy, Gdansk
Wojewodzki Specjalistityczny Szpital Dziect Im Sw Ludwika, Krakow
Dziecięcy Szpital Kliniczny im. Prof. Antoniego Gębali, Lublin
Szpital Kliniczny im Karola Jonschera, Poznan
NZOZ Sanatorium Cassia Villa Medica, Rabka-Zdrój
NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii, Rzeszów
Children's Health Memorial Institute, Warsaw
Lead Sponsor
Forest Laboratories
INDUSTRY