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

NCT ID: NCT00102817

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Growth Hormone Disorder Pituitary Dwarfism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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somatropin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Los Angeles, California, United States

Site Status

Novo Nordisk Investigational Site

San Diego, California, United States

Site Status

Novo Nordisk Investigational Site

Stanford, California, United States

Site Status

Novo Nordisk Investigational Site

St. Petersburg, Florida, United States

Site Status

Novo Nordisk Investigational Site

Tallahassee, Florida, United States

Site Status

Novo Nordisk Investigational Site

Tampa, Florida, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Worcester, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Kalamazoo, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

Kansas City, Missouri, United States

Site Status

Novo Nordisk Investigational Site

Brooklyn, New York, United States

Site Status

Novo Nordisk Investigational Site

Buffalo, New York, United States

Site Status

Novo Nordisk Investigational Site

Rockville Centre, New York, United States

Site Status

Novo Nordisk Investigational Site

The Bronx, New York, United States

Site Status

Novo Nordisk Investigational Site

Akron, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Cincinnati, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Novo Nordisk Investigational Site

Hershey, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Columbia, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

San Antonio, Texas, United States

Site Status

Novo Nordisk Investigational Site

Seattle, Washington, United States

Site Status

Novo Nordisk Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Cohen P, Rogol A, Kappelgaard A-M, Weng W, Germak J, Rosenfeld RG on behalf of the American Norditropin Study Group. Efficacy of IGF-I Based Growth Hormone (GH) Dose Titration in Non-GH Deficient (Non-GHD) Children with Short Stature Associated with IGF-I Deficiency (IGFD). Pediatric Academic Societies (PAS)/Lawson Wilkins Pediatric Endocrine Society (LWPES) 2007; Country: Canada City: Toronto

Reference Type RESULT

Cohen P, Rosenfeld R, Rogol A, Kappelgaard A-M, Mak C, Germak J. Validation of the Efficacy and Safety of IGF-based Dose-titration in Children with Growth Failure Associated with Non-GH-deficient, IGF-I Deficiency: Results of Clinical Trial HGH 2147 on Behalf of the American Norditropin® Clinical Studies Group. 3rd International Congress of the Growth Hormone Research Society and the IGF Society 2006; Country: Japan City: Kobe

Reference Type RESULT

Cohen P, Rogol AD, Weng W, Kappelgaard AM, Rosenfeld RG, Germak J; American Norditropin Study Group. Efficacy of IGF-based growth hormone (GH) dosing in nonGH-deficient (nonGHD) short stature children with low IGF-I is not related to basal IGF-I levels. Clin Endocrinol (Oxf). 2013 Mar;78(3):405-14. doi: 10.1111/cen.12014.

Reference Type DERIVED
PMID: 22924571 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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HGH-2147

Identifier Type: -

Identifier Source: org_study_id

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