CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 57 enrolled
Drug / intervention
Genotonorm (Somatropin)drug
Likely dose
0.40 mg/kg/week divided into 7 daily subcutaneous injectionsAI-extracted
Key inclusion· 2
  • ✓Chronological age 4-9 years for boys, 4-7 years for girls
  • ✓Measured height below -2.5 standard deviations
Key exclusion· 2
  • ✕Pubertal signs: testis volume ≥4 mL in boys or breast stage ≥B2 (Tanner) in girls
  • ✕Serious chronic disease including diabetes, renal insufficiency, heart failure, hepatic insufficiency, or neoplasia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00174252
NCT00174252Phase 3Completed
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Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.

Pfizer·interventional·Posted Sep 15, 2005·Updated Jun 15, 2010

In Brief

A Phase 3 clinical trial evaluating Genotonorm (Somatropin) for Fetal Growth Retardation. Completed, enrolled 57 participants across 22 sites.

Detailed Summary

To estimate the percentage of children with serum IGF-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFetal Growth Retardation
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartFeb 1, 2005
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 20.8 years ago

Interventions

Genotonorm (Somatropin)drug

0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years