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Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children

NCT02879747 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2019-04-30

Study results available
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Summary

The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).

Conditions

  • Short Stature

Interventions

DRUG

Genotropin

Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Göteborg University

    lead OTHER

Principal Investigators

  • Berit Kriström, MD · Umeå University Hospital

  • Nils-Östen Nilsson, MD · Halmstad Department of Pediatrics

  • Maria Halldin, MD · Uppsala University Hospital

  • Sten Ivarsson, MD, Prof · Malmö Academic Hospital

  • Kerstin Albertsson-Wikland, MD, prof · Gothenburg University, Departments of pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2012-03-31
Completion
2017-12-31

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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 NCT02879747 on ClinicalTrials.gov