Surveillance of Treatment of Children With Growth Hormone... | NCT01731028

Studies
Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®

NCT01731028

Sponsor

Ferring Pharmaceuticals

Status

Withdrawn

Last Update Posted

Feb 1, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Growth Hormone Deficiency

Interventions

Somatropin

Countries

Not provided

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change of local requirements

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2017Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Nov 16, 2012

First Submission Date that Met QC Criteria

Nov 16, 2012

First Posted Date

Nov 21, 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

Jan 31, 2013

Last Update Posted Date

Feb 1, 2013Estimated

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

The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.

Detailed Description

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Somatropin		Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization	Drug: Somatropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somatropin	Drug	Somatropin powder and solvent for solution for injection	Somatropin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of Zomacton® treatment measured by the increase in body height per annuum		5 years

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of Zomacton® treatment measured by the increase in body weight per annuum		5 years
Safety of Zomacton® and the application device measured by local adverse reactions to the application device		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

therapeutic need according to the approved specific products characteristics (SPC)

Exclusion Criteria:

contraindication according to the SPC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with inadequate secretion of growth-hormone; growth retardation due to Turner's syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

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