CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 75 enrolled
Drug / intervention
somatropin +1 moredrug
Likely dose
somatropin 3 IUfrom 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/NCT01697644
NCT01697644Phase 4Completed
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Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Novo Nordisk A/S·interventional·Posted Oct 2, 2012·Updated Jan 18, 2017

In Brief

A Phase 4 clinical trial evaluating somatropin for Foetal Growth Problem and Small for Gestational Age. Completed, enrolled 75 participants across 2 sites.

Detailed Summary

This trial is conducted in Europe. The aim of this trial is to assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFoetal Growth Problem, Small for Gestational Age
CountriesNetherlands
Collaborators--

Timeline

Phase 4CompletedFinished
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First PostedOct 2, 2012
Enrollment StartOct 1, 1990
Primary CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 14.6 yearsPosted 13.8 years ago

Interventions

somatropindrug

3 IU/m\^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily

somatropindrug

3 IU/m\^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily