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Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Growth Hormone Deficiency in Children

Intervention: somatropin (Drug); somatropin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Stephanie Seremetis, MD, Study Director, Affiliation: Novo Nordisk A/S

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Adverse events (especially injection site reactions)

Serious adverse events

Secondary outcome:

IGF-1 (Insulin-like growth factor 1) concentration

IGFBP-3 (Insulin-like growth factor binding protein 3) concentration

Eligibility

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90027, United States

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90048, United States

Novo Nordisk Clinical Trial Call Center, Washington, District of Columbia 20010, United States

Novo Nordisk Clinical Trial Call Center, Gainesville, Florida 32610, United States

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33155, United States

Novo Nordisk Clinical Trial Call Center, Orlando, Florida 32806-1101, United States

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33607, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60611, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60612, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60614, United States

Novo Nordisk Clinical Trial Call Center, Wichita, Kansas 67211, United States

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40536-0284, United States

Novo Nordisk Clinical Trial Call Center, Louisville, Kentucky 40202, United States

Novo Nordisk Clinical Trial Call Center, Worcester, Massachusetts 01655, United States

Novo Nordisk Clinical Trial Call Center, Manhasset, New York 11030, United States

Novo Nordisk Clinical Trial Call Center, Akron, Ohio 44308-1062, United States

Novo Nordisk Clinical Trial Call Center, Hershey, Pennsylvania 17033, United States

Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15212, United States

Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15224, United States

Novo Nordisk Clinical Trial Call Center, Seattle, Washington 98105, United States

Additional Information

Clinical Trials at Novo Nordisk

Starting date: May 2001
Last updated: July 11, 2012

Page last updated: August 23, 2015

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