Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants

PHASE3TerminatedINTERVENTIONAL
Enrollment

415

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

July 31, 2013

Study Completion Date

August 31, 2014

Conditions
Prevention of Growth Restriction
Interventions
DRUG

rhBSSL (recombinant human bile-salt-stimulated lipase)

rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

DRUG

Placebo

Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.

Trial Locations (49)

Unknown

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

Sponsors
All Listed Sponsors
lead

Swedish Orphan Biovitrum

INDUSTRY