At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 99 enrolled
Drug / intervention
Genotropindrug
Likely dose
Genotropin at either 50% reduced dose or unchanged dose (exact dose not specified in study text)AI-extracted
Key inclusion· 4
- ✓Prior participation in the GH-dose catch-up study 98-0198-003
- ✓Midparental height achieved (difference <0.6 SDS)
- ✓Prepubertal status: girls Tanner ≤1, boys testes <3 mL
- ✓Signed written informed consent from parents (and child if old enough)
Key exclusion· 3
- ✕Disease affecting growth other than treated hypothyroidism
- ✕Puberty: breast stage >2 or testes >4 mL
- ✕Incapable of following study protocol or poor compliance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003
In Brief
A Phase 3 clinical trial evaluating Genotropin for Short Stature. Completed, enrolled 99 participants.
Detailed Summary
The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Stature
Countries--
CollaboratorsPfizer
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2003
Primary CompletionMar 2012
First PostedAug 2016
Study CompletionDec 2017
TodayJul 2026
First PostedAug 26, 2016
Enrollment StartDec 1, 2003
Primary CompletionMar 1, 2012
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 9.8 years ago
Interventions
Genotropindrug
Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth