CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 enrolled
Drug / intervention
Somatropindrug
Likely dose
Somatropin 0.46 mg/kg/week (maximum 50 µg/kg/day), daily for 3 years extendable to 5 yearsAI-extracted
Key inclusion· 4
  • ✓Glucocorticosteroid treatment for at least 12 months
  • ✓Bone age less than 15 years in boys, less than 13 years in girls
  • ✓Child measured height below -2 standard deviations
  • ✓Currently treated by growth hormone
Key exclusion· 2
  • ✕Known diabetes (type 1 or type 2)
  • ✕Previous history of intolerance or hypersensitivity to somatropin or chemically similar drugs

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

Search/NCT00163189
NCT00163189Phase 3Completed
CompareCT.gov

Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm

Pfizer·interventional·Posted Sep 13, 2005·Updated Feb 21, 2024

In Brief

A Phase 3 clinical trial evaluating Somatropin for Growth Hormone Deficiency. Completed, enrolled 98 participants across 19 sites.

Detailed Summary

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2005
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 20.8 years ago

Interventions

Somatropindrug

Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day