Effect of Growth Hormone in Children With Growth Hormone Deficiency

January 17, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90095
        • Novo Nordisk Investigational Site
      • Sacramento, California, United States, 95817
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92093
        • Novo Nordisk Investigational Site
      • Stanford, California, United States, 94305-5208
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Novo Nordisk Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32608
        • Novo Nordisk Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Novo Nordisk Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
      • Minneapolis, Minnesota, United States, 55455
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Novo Nordisk Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Novo Nordisk Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Novo Nordisk Investigational Site
      • Brooklyn, New York, United States, 11219
        • Novo Nordisk Investigational Site
      • Buffalo, New York, United States, 14222
        • Novo Nordisk Investigational Site
      • New Hyde Park, New York, United States, 11042
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10029
        • Novo Nordisk Investigational Site
      • Stony Brook, New York, United States, 11794
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43205
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novo Nordisk Investigational Site
      • Columbia, South Carolina, United States, 29203
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Novo Nordisk Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78284
        • Novo Nordisk Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-0509
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in height standard deviation score
Time Frame: 24 month
24 month

Secondary Outcome Measures

Outcome Measure
IGF-I
IGFBP-3
free IGF-I

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

December 5, 2005

First Submitted That Met QC Criteria

December 5, 2005

First Posted (Estimate)

December 6, 2005

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGH-2051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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