Growth Hormone Treatment in Children Born Small for Gesta... | NCT00519844

Studies
Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

NCT00519844

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Nov 13, 2015Estimated

Enrollment

5Actual

Phase

Phase 4

Conditions

Foetal Growth Problem
Small for Gestational Age

Interventions

somatropin

Countries

France

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

ID	Type	Description	Link
2005-000318-11	EudraCT Number

Status Module

Record Verification Date

Nov 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

Jul 2005

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Aug 22, 2007

First Submission Date that Met QC Criteria

Aug 22, 2007

First Posted Date

Aug 23, 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

Nov 11, 2015

Last Update Posted Date

Nov 13, 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 trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.

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

5Actual

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference		after 3 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Clinical (adverse events)
Biological (fasting glucose, fasting insulin, liver enzymes)
Tolerance of the treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children treated for 3 years with Maxomat® because of small for gestational age
Postnatal growth failure by the age of 3 years or more
No associated growth hormone deficiency
Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
Bone age no more than 13 years for girls and no more than 15 years for boys

Exclusion Criteria:

Known, evolving tumour
Hypertrophic cardiomyopathy
Hypertension not controlled on maximum therapy
Benign intracranial hypertension
Known glucose intolerance or known diabetes mellitus
Acute or active chronic hepatitis
Chronic renal failure
Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

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
		Lyon		69000	France

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