415
Participants
Start Date
May 31, 2011
Primary Completion Date
July 31, 2013
Study Completion Date
August 31, 2014
rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.
Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Swedish Orphan Biovitrum Investigational Site, Bruges
Swedish Orphan Biovitrum Investigational Site, Leuven
Swedish Orphan Biovitrum Investigational Site, Liège
Swedish Orphan Biovitrum Investigational Site, Rocourt
Swedish Orphan Biovitrum Investigational Site, Wilrijk
Swedish Orphan Biovitrum Investigational Site, Hradec Králové
Swedish Orphan Biovitrum Investigational Site, Olomouc
Swedish Orphan Biovitrum Investigational Site, Prague
Swedish Orphan Biovitrum Investigational Site, Zlín
Swedish Orphan Biovitrum Investigational Site, Amiens
Swedish Orphan Biovitrum Investigational Site, Lille
Swedish Orphan Biovitrum Investigational Site, Nancy
Swedish Orphan Biovitrum Investigational Site, Paris
Swedish Orphan Biovitrum Investigational Site, Rouen
Swedish Orphan Biovitrum Investigational Site, Strasbourg
Swedish Orphan Biovitrum Investigational Site, Toulouse
Swedish Orphan Biovitrum Investigational Site, Berlin
Swedish Orphan Biovitrum Investigational Site, Freiburg im Breisgau
Swedish Orphan Biovitrum Investigational Site, Heidelberg
Swedish Orphan Biovitrum Investigational Site, Wiesbaden
Swedish Orphan Biovitrum Investigational Site, Budapest
Swedish Orphan Biovitrum Investigational Site, Gyula
Swedish Orphan Biovitrum Investigational Site, Miskolc
Swedish Orphan Biovitrum Investigational Site, Nyíregyháza
Swedish Orphan Biovitrum Investigational Site, Pécs
Swedish Orphan Biovitrum Investigational Site, Veszprém
Swedish Orphan Biovitrum Investigational Site, Ancona
Swedish Orphan Biovitrum Investigational Site, Bari
Swedish Orphan Biovitrum Investigational Site, Foggia
Swedish Orphan Biovitrum Investigational Site, Milan
Swedish Orphan Biovitrum Investigational Site, Padua
Swedish Orphan Biovitrum Investigational Site, Roma
Swedish Orphan Biovitrum Investigational Site, Bydgoszcz
Swedish Orphan Biovitrum Investigational Site, Gdansk
Swedish Orphan Biovitrum Investigational Site, Lodz
Swedish Orphan Biovitrum Investigational Site, Poznan
Swedish Orphan Biovitrum Investigational Site, Warsaw
Swedish Orphan Biovitrum Investigational Site, Ivanovo
Swedish Orphan Biovitrum Investigational Site, Nizhny Novgorod
Swedish Orphan Biovitrum Investigational Site, Almería
Swedish Orphan Biovitrum Investigational Site, Cadiz
Swedish Orphan Biovitrum Investigational Site, Córdoba
Swedish Orphan Biovitrum Investigational Site, Madrid
Swedish Orphan Biovitrum Investigational Site, Málaga
Swedish Orphan Biovitrum Investigational Site, Oviedo
Swedish Orphan Biovitrum Investigational Site, Salamanca
Swedish Orphan Biovitrum Investigational Site, Santiago de Compostela
Swedish Orphan Biovitrum Investigational Site, Stockholm
Swedish Orphan Biovitrum Investigational Site, Umeå
Lead Sponsor
Swedish Orphan Biovitrum
INDUSTRY