Effect of Growth Hormone in Children With Growth Hormone Deficiency - Tabular View

Tracking Information

First Received Date ^ICMJE

December 5, 2005

Last Updated Date

October 1, 2009

Start Date ^ICMJE

August 2000

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in height standard deviation score [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

24 month change in height standard deviation score

Change History

Complete list of historical versions of study NCT00262249 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

IGF-I [ Designated as safety issue: No ]
IGFBP-3 [ Designated as safety issue: No ]
free IGF-I [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

IGF-I
IGFBP-3
free IGF-I

Descriptive Information

Brief Title ^ICMJE

Effect of Growth Hormone in Children With Growth Hormone Deficiency

Official Title ^ICMJE

Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Growth Hormone Deficiency (GHD)
Idiopathic Short Stature

Intervention ^ICMJE

Drug: somatropin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

173

Completion Date

May 2004

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

3 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00262249

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

HGH-2051

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Campbell Howard, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP