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Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age

NCT00249821 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-09-26

Study results available
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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.

Conditions

  • Small Gestational Age (SGA)

Interventions

DRUG

Saizen®

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.

DRUG

Saizen®

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.

Sponsors & Collaborators

  • Merck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany

    collaborator UNKNOWN

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Serono S.A.S, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-09-30
Completion
2007-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00249821 on ClinicalTrials.gov