Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2013

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Idiopathic Short Stature
Interventions
DRUG

Nutropin [Somatropin (rDNA origin) for injection]

Doses in the diagnostic protocol are 0.7 and 1.4 mg/m2/day, injected by subcutaneous injection at bedtime for 2 weeks, divided by washout periods of preferably 4 weeks (accepted range 4-6 weeks). An additional period of 2 weeks on 2.8 mg/m2/day (after a washout period of 4-6 weeks) will be added if the IGF-I response on either dosage is insufficient (serum IGF-I SDS \<0).

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY