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NCT00262249 Clinical Trial

Effect of Growth Hormone in Children With Growth Hormone Deficiency

Growth Hormone Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00262249
Other study ID # HGH-2051
Secondary ID
Status Completed
Phase Phase 3
First received December 5, 2005
Last updated January 17, 2017
Start date August 2000
Est. completion date May 2004

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 173
Est. completion date May 2004
Est. primary completion date May 2004
Accepts healthy volunteers No
Gender All
Age group 3 Years to 15 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin

Locations
Country Name City State
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Bronx New York
United States Novo Nordisk Investigational Site Brooklyn New York
United States Novo Nordisk Investigational Site Buffalo New York
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Cleveland Ohio
United States Novo Nordisk Investigational Site Cleveland Ohio
United States Novo Nordisk Investigational Site Columbia South Carolina
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Gainesville Florida
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Kalamazoo Michigan
United States Novo Nordisk Investigational Site Kansas City Missouri
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Morristown New Jersey
United States Novo Nordisk Investigational Site New Haven Connecticut
United States Novo Nordisk Investigational Site New Hyde Park New York
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Sacramento California
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site Seattle Washington
United States Novo Nordisk Investigational Site Shreveport Louisiana
United States Novo Nordisk Investigational Site Skokie Illinois
United States Novo Nordisk Investigational Site Springfield Massachusetts
United States Novo Nordisk Investigational Site St. Petersburg Florida
United States Novo Nordisk Investigational Site Stanford California
United States Novo Nordisk Investigational Site Stony Brook New York
United States Novo Nordisk Investigational Site Tallahassee Florida
United States Novo Nordisk Investigational Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen P, Rogol AD, Howard CP, Bright GM, Kappelgaard AM, Rosenfeld RG; American Norditropin Study Group.. Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study. J Clin Endocrinol Metab. 2007 Jul;92(7):248 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in height standard deviation score 24 month
Secondary IGF-I
Secondary IGFBP-3
Secondary free IGF-I
See also
  Status Clinical Trial Phase
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Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT01562834 - Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Phase 4
Completed NCT01109017 - Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency N/A
Completed NCT01706783 - A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency Phase 1
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
Completed NCT00184730 - Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT01502124 - Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency Phase 3
Completed NCT00519558 - Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT01604161 - Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome N/A
Completed NCT00102817 - Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children Phase 3
Terminated NCT01698944 - Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency Phase 4
Completed NCT03075644 - A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency Phase 3
Recruiting NCT02616562 - Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency Phase 2
Completed NCT02005198 - Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) N/A
Completed NCT00567385 - Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 4
Completed NCT01009905 - An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) N/A
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Completed NCT00934063 - An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® N/A
Completed NCT00722540 - Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 1

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