Liquid Somatropin Formulation in Children With Growth Hor... | NCT00567385

Studies
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

NCT00567385

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 28, 2017Actual

Enrollment

176Actual

Phase

Phase 4

Conditions

Growth Hormone Disorder
Growth Hormone Deficiency in Children

Interventions

somatropin

Countries

Turkey (Türkiye)

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

Feb 2017

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

Mar 10, 2003Actual

Primary Completion Date

Mar 22, 2004Actual

Completion Date

Mar 22, 2004Actual

First Submitted Date

Nov 30, 2007

First Submission Date that Met QC Criteria

Dec 3, 2007

First Posted Date

Dec 4, 2007Estimated

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

Feb 27, 2017

Last Update Posted Date

Feb 28, 2017Actual

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 trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug

Measure	Description	Time Frame
Assessment of acceptance		after 12 weeks of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Growth failure due to growth hormone insufficiency (GHD)
Turner syndrome: established diagnosis according to sex chromosome analysis, or
Growth retardation in children with chronic renal disorders

Exclusion Criteria:

Pregnancy
Breast feeding women
Suspected or know allergy to trial product
Participating in any other trial involving other investigational products within the last 3 months
Previous participation in the trial
Other daily injection therapy (non-growth hormone, e.g insulin-therapy)

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

Not provided

Sampling Method

Not provided

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
Novo Nordisk Investigational Site		Altunizade-Istanbul		34662	Turkey (Türkiye)

Label	URL
Clinical Trials at Novo Nordisk	View source

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