Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

NCT00184691 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-01-18

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Conditions

  • Foetal Growth Problem
  • Small for Gestational Age

Interventions

DRUG

somatropin

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-04-30
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • Spain

Study Locations

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Entities

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 NCT00184691 on ClinicalTrials.gov