Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

PHASE4CompletedINTERVENTIONAL
Enrollment

278

Participants

Timeline

Start Date

February 6, 2008

Primary Completion Date

March 25, 2022

Study Completion Date

March 25, 2022

Conditions
Small for Gestational Age
Interventions
DRUG

Omnitrope

All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.

Trial Locations (31)

144

Sandoz Investigational Site, Tbilisi

1023

Sandoz Investigational Site, Budapest

1094

Sandoz Investigational Site, Budapest

2650

Sandoz Investigational Site, Edegem

3526

Sandoz Investigational Site, Miskolc

6720

Sandoz Investigational Site, Szeged

9024

Sandoz Investigational Site, Győr

25734

Sandoz Investigational Site, Kielce

53757

Sandoz Investigational Site, Sankt Augustin

80337

Sandoz Investigational Site, Munich

200642

Sandoz Investigational Site, Craiova

400370

Sandoz Investigational Site, Cluj-Napoca

700111

Sandoz Investigational Site, Iași

150 06

Sandoz Investigational Site, Prague

500 05

Sandoz Investigational Site, Hradec Králové

400 11

Sandoz Investigational Site, Ústí nad Labem

60-572

Sandoz Investigational Site, Poznan

85-667

Sandoz Investigational Site, Bydgoszcz

50-368

Sandoz Investigational Site, Wroclaw

35-301

Sandoz Investigational Site, Rzeszów

40-752

Sandoz Investigational Site, Katowice

Sandoz Investigational Site, Katowice

41-800

Sandoz Investigational Site, Zabrze

80-952

Sandoz Investigational Site, Gdansk

30-663

Sandoz Investigational Site, Krakow

93-338

Sandoz Investigational Site, Lodz

71-252

Sandoz Investigational Site, Szczecin

04-730

Sandoz Investigational Site, Warsaw

51-312

Sandoz Investigational Site, Wroclaw

011461

Sandoz Investigational Site, Bucharest

020395

Sandoz Investigational Site, Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY

NCT00537914 - Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA) | Biotech Hunter | Biotech Hunter