CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 316 enrolled
Drug / intervention
Genotropin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00396097
NCT00396097Phase 3Completed
CompareCT.gov

A Four Year Open Label Multi Center Randomized Two Arm Study Of Genotropin In Idiopathic Short Stature Patients: Comparing An Individualized, Target Driven Treatment Regimen To Standard Dosing Of Genotropin

Pfizer·interventional·Posted Nov 6, 2006·Updated Apr 5, 2016

In Brief

A Phase 3 clinical trial evaluating Genotropin for Idiopathic Short Stature. Completed, enrolled 316 participants across 43 sites.

Detailed Summary

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Short Stature
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2006
Enrollment StartDec 1, 2006
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 19.7 years ago

Interventions

Genotropindrug

Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Genotropindrug

Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.