CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 251 enrolled
Drug / intervention
Somatropin (rDNA origin)drug
Likely dose
Somatropin 0.025–0.05 mg/kg/day, subcutaneous injection dailyAI-extracted
Key inclusion· 2
  • ✓Children under 18 years old
  • ✓Growth failure associated with inadequate growth hormone secretion, Turner syndrome, or chronic renal insufficiency
Key exclusion· 3
  • ✕Closed epiphyses
  • ✕Active neoplasm (cancer)
  • ✕Acute critical illness

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

Search/NCT00234533
NCT00234533Phase 3Completed
CompareCT.gov

Phase IIIB, International, Single Group, Open Study to Define an Optimal Monitoring of IGF-1 in Children Treated With NutropinAq, Using a Novel Capillary Blood Collection Method

Ipsen·interventional·Posted Oct 7, 2005·Updated Dec 9, 2019

In Brief

A Phase 3 clinical trial evaluating Somatropin (rDNA origin) for Turner Syndrome and 3 related conditions. Completed, enrolled 251 participants across 45 sites in 14 countries.

Detailed Summary

The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTurner Syndrome, Renal Insufficiency, Chronic, Pituitary Diseases, Dwarfism
CountriesBelgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Romania, Russia, Slovakia, Spain, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 7, 2005
Enrollment StartJun 1, 2004
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.7 years ago

Interventions

Somatropin (rDNA origin)drug

Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.