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Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

NCT01697644 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

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 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).

Conditions

  • Foetal Growth Problem
  • Small for Gestational Age

Interventions

DRUG

somatropin

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

DRUG

somatropin

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

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1990-10-31
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • Netherlands

Study Locations

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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 NCT01697644 on ClinicalTrials.gov