NCT00625872

Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.

Conditions

• Growth Hormone Therapy
• Infant, Small for Gestational Age

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-02-28
• Last updated: 2012-02-29
• Results posted: 2012-02-29

Locations

10 sites across 1 country: Germany