Skip to content

Trial · Interventional

CompletedPhase 3Registry data

Effect of Growth Hormone in Children With Growth Hormone Deficiency

NCTNCT00262249 (opens ClinicalTrials.gov in a new tab)Other idHGH-2051
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
173 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2000
Primary completion
May 2004
Completion
May 2004
First posted
6 Dec 2005 (estimated)
Last update posted
18 Jan 2017 (estimated)
Conditions
Growth Hormone Disorder · Growth Hormone Deficiency in Children · Growth Disorder · Idiopathic Short Stature

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200020012002200320042005
  1. Ph 3

    Effect of Growth Hormone in Children With Growth Hormone Deficiency

    NCT00262249

    Aug 2000 to May 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

Interventions

  • somatropinDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in height standard deviation score

    Time frame · 24 month

Secondary outcomes(3)

  1. IGF-I

  2. IGFBP-3

  3. free IGF-I

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2007

8 results

Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study.

Cohen et al. 2007The Journal of clinical endocrinology and metabolismcited by 100

PMID 17356043DOI 10.1210/jc.2007-0204PUB-17356043

Rights unknown8 results
Source linkSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 15 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Clinically suspected GHD * Height \< -2.0 SDS * Serum IGF-I less than or equal to -1.0 SDS * Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls. * Puberty Tanner Stage I Exclusion Criteria: * Previous use of growth hormone * Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.) * Intrauterine growth retardation: birth weight \< 3rd percentile. * Administration of other growth-altering medications. * Evidence of any malignancy or intracranial tumors.

PepBank is a research reference. Talk to a doctor before you use any peptide.