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NCT01502124 Clinical Trial

Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Growth Hormone Disorder Clinical Trial

Official title:
Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01502124
Other study ID # HGH-2124
Secondary ID
Status Completed
Phase Phase 3
First received December 29, 2011
Last updated February 27, 2017
Start date May 8, 2001
Est. completion date March 5, 2003

Study information
Verified date February 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 aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date March 5, 2003
Est. primary completion date March 5, 2003
Accepts healthy volunteers No
Gender All
Age group 3 Years to 17 Years
Eligibility Inclusion Criteria:

- Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)

- Naïve to growth hormone therapy

Exclusion Criteria:

- Known or suspected allergy to the trial product or related products

- Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)

- Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age

- Pregnancy or the intention to become pregnant

- Breast-feeding

- Administration of other growth-altering medication

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
• somatropin
Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists

Locations
Country Name City State
United States Novo Nordisk Investigational Site Akron Ohio
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Gainesville Florida
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Louisville Kentucky
United States Novo Nordisk Investigational Site Manhasset New York
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Orlando Florida
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Seattle Washington
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Washington District of Columbia
United States Novo Nordisk Investigational Site Wichita Kansas
United States Novo Nordisk Investigational Site Wilmington Delaware
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, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events (especially injection site reactions)
Primary Serious adverse events
Secondary IGF-1 (Insulin-like growth factor 1) concentration
Secondary IGFBP-3 (Insulin-like growth factor binding protein 3) concentration
See also
  Status Clinical Trial Phase
Completed NCT02229851 - Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. Phase 3
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 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
Completed NCT00715689 - Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 2

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