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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started May 2001

Geographic Reach

1 country

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

May 8, 2001

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2003

Completed

8.8 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed

Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

December 29, 2011

Last Update Submit

February 27, 2017

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (2)

Adverse events (especially injection site reactions)
Serious adverse events

Secondary Outcomes (2)

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

Study Arms (2)

Lyophilized

ACTIVE COMPARATOR

Drug: somatropin

Liquid

EXPERIMENTAL

Drug: somatropin

Interventions

somatropinDRUG

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

Lyophilized

Eligibility Criteria

Age3 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.