Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Phase 3

Completed

• Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children
• Interventions: Drug: somatropin

• Registration Number: NCT01502124
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05-08
• Primary Completion: 2003-03-05
• Study Completion: 2003-03-05
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liquid	somatropin	-
Lyophilized	somatropin	-

Primary Outcome Measures

Name	Time	Method
Serious adverse events
Adverse events (especially injection site reactions)

Secondary Outcome Measures

Name	Time	Method
IGFBP-3 (Insulin-like growth factor binding protein 3) concentration
IGF-1 (Insulin-like growth factor 1) concentration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Seattle, Washington, United States