Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children

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

Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.

This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

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

    • California
      • Los Angeles, California, United States, 90027
        • Novo Nordisk INvestigational Site
      • San Diego, California, United States, 92093
        • Novo Nordisk INvestigational Site
      • Stanford, California, United States, 94305-5208
        • Novo Nordisk INvestigational Site
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Novo Nordisk INvestigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk INvestigational Site
      • Tampa, Florida, United States, 33607
        • Novo Nordisk INvestigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5225
        • Novo Nordisk INvestigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • 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
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • 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
      • Rockville Centre, New York, United States, 11570
        • Novo Nordisk INvestigational Site
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Novo Nordisk INvestigational Site
      • Cincinnati, Ohio, United States, 45229
        • Novo Nordisk INvestigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk INvestigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk INvestigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk INvestigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk INvestigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Novo Nordisk INvestigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • 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 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 3-15
  • Presence of growth failure indicated by height standard deviation score less than equal to -2
  • Body mass index greater than or equal to 25th percentile for height age
  • IGF concentration less than or equal to 33rd percentile

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: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
12 months change in height standard deviation score adjusted for parent height z-score

Collaborators and Investigators

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

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

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

May 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 1, 2005

First Submitted That Met QC Criteria

February 1, 2005

First Posted (Estimate)

February 2, 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

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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