CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 22 enrolled
Drug / intervention
Saizen® +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/NCT00249821
NCT00249821Phase 3Completed
CompareCT.gov

Optimization of the Dosage Regimen With Growth Hormone Therapy in Children Born Small for Gestational Age. An Open Label, Randomized, Pilot Study, Comparing in Children Treated for 3 Years, the Efficacy of a Saizen® Treatment at the Same Dose Versus a Lower Maintenance Dose Prolonged During 1 Additional Year.

Merck KGaA, Darmstadt, Germany·interventional·Posted Nov 7, 2005·Updated Sep 26, 2017

In Brief

A Phase 3 clinical trial evaluating Saizen® for Small Gestational Age (SGA). Completed, enrolled 22 participants.

Detailed Summary

Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen® during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH) therapy with 0.057 mg/kg/day in both groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Gestational Age (SGA)
Countries--
CollaboratorsMerck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2005
Enrollment StartFeb 28, 2005
Primary CompletionSep 30, 2007
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.7 years ago

Interventions

Saizen®drug

Saizen® \[somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.

Saizen®drug

Saizen® \[somatropin (rDNA origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.