CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 46 enrolled
Drug / intervention
Somatropindrug
Likely dose
0.0033–0.0067 mg/kg/day, adjusted based on IGF-1 level and weightAI-extracted
Key inclusion· 3
  • ✓Bone age less than 13 years (boys) or less than 11 years (girls)
  • ✓Height at least 2.5 standard deviations below mean for chronological age
  • ✓Treatment-naive or currently receiving growth hormone therapy
Key exclusion· 2
  • ✕Idiopathic short stature (short stature without identifiable underlying disease)
  • ✕Known syndrome associated with increased cancer risk, including family history of adenomatous polyposis

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

Search/NCT00163215
NCT00163215Phase 3Completed
CompareCT.gov

Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.

Pfizer·interventional·Posted Sep 13, 2005·Updated Dec 19, 2012

In Brief

A Phase 3 clinical trial evaluating Somatropin for Endocrine System Diseases. Completed, enrolled 46 participants across 18 sites.

Detailed Summary

To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndocrine System Diseases
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2005
Enrollment StartJan 1, 2005
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.8 years ago

Interventions

Somatropindrug

Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years