Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

PHASE3TerminatedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Growth Hormone TherapyInfant, Small for Gestational Age
Interventions
DRUG

Somatropin

Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.

DRUG

Somatropin

Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.

Trial Locations (10)

13353

Pfizer Investigational Site, Berlin

24105

Pfizer Investigational Site, Kiel

45122

Pfizer Investigational Site, Essen

45711

Pfizer Investigational Site, Datteln

50937

Pfizer Investigational Site, Cologne

53113

Pfizer Investigational Site, Bonn

69120

Pfizer Investigational Site, Heidelberg

80337

Pfizer Investigational Site, München

91054

Pfizer Investigational Site, Erlangen

01307

Pfizer Investigational Site, Dresden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY