Clinical Trials/NCT01697644

NCT01697644

Completed

Phase 4

Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Novo Nordisk A/S1 site in 1 country75 target enrollmentOctober 1990

ConditionsFoetal Growth Problem Small for Gestational Age

Interventionssomatropin

Drugssomatropin

Overview

Phase: Phase 4
Intervention: somatropin
Conditions: Foetal Growth Problem
Sponsor: Novo Nordisk A/S
Enrollment: 75
Locations: 1
Primary Endpoint: Linear growth (height during childhood)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

October 1990

End Date

May 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Completion of the GHRETARD/BPD/20/NL trial
•Written informed consent from child and/or parents/guardians before continuation in the extension trial

Exclusion Criteria

Not provided

Arms & Interventions

Low dose

Intervention: somatropin

High dose

Intervention: somatropin

Outcomes

Primary Outcomes

Linear growth (height during childhood)

Final height

Bone maturation

Pubertal development

Secondary Outcomes

Adverse events

Study Sites (1)

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