Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

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.

Timeline

Start

2008-07

Primary completion

2011-03

Completion

2011-03

Outcome

Missed primary endpoint

Stopped (Enrollment): “The study terminated on 19-Jan-2011 due to insufficient recruitment of patients. No safety reasons contributed to the termination of the study.”

registry Somatropin vs Control Arm; p = 0.7232; Least squares (LS) mean difference -0.43 (95% CI -3.93 to 3.08) NCT00625872 ↗

registry Somatropin vs Control Arm; p = 0.1941; LS Mean difference -1.61 (95% CI -8.04 to 4.82) NCT00625872 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	0.035 mg/kg	—
Subject	Somatropin	Protein / enzyme biologic	0.067 mg/kg	—

Indications