22
Participants
Start Date
October 21, 1998
Primary Completion Date
December 1, 2002
Study Completion Date
December 1, 2002
somatropin
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.
placebo
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.
Novo Nordisk Investigational Site, Marseille Cédex 05
Novo Nordisk Investigational Site, Caen
Novo Nordisk Investigational Site, Brest
Novo Nordisk Investigational Site, Toulouse
Novo Nordisk Investigational Site, Montpellier
Novo Nordisk Investigational Site, Rennes
Novo Nordisk Investigational Site, Tours
Novo Nordisk Investigational Site, Grenoble
Novo Nordisk Investigational Site, Nantes
Novo Nordisk Investigational Site, Nantes
Novo Nordisk Investigational Site, Angers
Novo Nordisk Investigational Site, Reims
Novo Nordisk Investigational Site, Vandœuvre-lès-Nancy
Novo Nordisk Investigational Site, Lorient
Novo Nordisk Investigational Site, Lille
Novo Nordisk Investigational Site, Strasbourg
Novo Nordisk Investigational Site, Lyon
Novo Nordisk Investigational Site, Lyon
Novo Nordisk Investigational Site, Paris
Novo Nordisk Investigational Site, Paris
Novo Nordisk Investigational Site, Paris
Novo Nordisk Investigational Site, Boisguillaume
Novo Nordisk Investigational Site, Le Kremlin-Bicêtre
Novo Nordisk Investigational Site, Nice
Lead Sponsor
Novo Nordisk A/S
INDUSTRY