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Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

NCT00537914 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2024-03-12

Study results available
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Summary

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Conditions

  • Small for Gestational Age

Interventions

DRUG

Omnitrope

All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.

Sponsors & Collaborators

Principal Investigators

  • Sandoz Biopharmaceuticals · Sandoz GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-06
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • Belgium
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Companies

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 NCT00537914 on ClinicalTrials.gov