Safety and Efficacy of Long-term Somatropin Treatment in... | NCT01543867

Studies
Safety and Efficacy of Long-term Somatropin Treatment in Children

NCT01543867

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 30, 2015Estimated

Enrollment

5,442Actual

Phase

Not provided

Conditions

Growth Hormone Disorder
Growth Hormone Deficiency in Children
Foetal Growth Problem
Small for Gestational Age
Genetic Disorder
Turner Syndrome
Growth Disorder
Idiopathic Short Stature

Interventions

somatropin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Feb 28, 2012

First Submission Date that Met QC Criteria

Feb 28, 2012

First Posted Date

Mar 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2015

Last Update Posted Date

Mar 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

Detailed Description

Not provided

Conditions Module

Conditions

Growth Hormone Disorder
Growth Hormone Deficiency in Children
Foetal Growth Problem
Small for Gestational Age
Genetic Disorder
Turner Syndrome
Growth Disorder
Idiopathic Short Stature

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,442Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Users of somatropin			Drug: somatropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug	Prescribed at the discretion of the treating physician according to product labelling	Users of somatropin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse events		Up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Number of patients continuing somatropin treatment		Up to 10 years
Change in height		Up to 10 years
Onset of puberty in children small for gestational age

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In need of somatropin or current user

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children treated with somatropin

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Mainz		55127	Germany

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D030342	Genetic Diseases, Inborn
D014424	Turner Syndrome
D006130	Growth Disorders

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006059	Gonadal Dysgenesis
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019382	Human Growth Hormone

Ancestor Terms

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided