An Observational Study on Treatment Compliance by Childre... | NCT01068639

Studies
An Observational Study on Treatment Compliance by Children Treated With Growth Hormone

NCT01068639

Sponsor

Novo Nordisk A/S

Status

Withdrawn

Last Update Posted

Jun 26, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Growth Hormone Disorder
Growth Hormone Deficiency in Children

Interventions

No treatment given

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

ID	Type	Description	Link
U1111-1113-2490	Other Identifier	WHO

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Apr 2010Estimated

Completion Date

Apr 2010Estimated

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 12, 2010

First Posted Date

Feb 15, 2010Estimated

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

Jun 25, 2014

Last Update Posted Date

Jun 26, 2014Estimated

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. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.

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
A			Behavioral: No treatment given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No treatment given	Behavioral	No treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average number of injections omitted during the previous month		measured over the past 2 months (retrospective data collection)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child treated for at least one year with growth hormone any growth hormone product
Followed by the participating paediatrician for at least 1 year.

Exclusion Criteria:

Refusal to participate
Child and/or parent unable to give consent or fill out the questionnaires
Child participating in a therapeutic trial

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 for at least one year with growth hormone with any growth hormone product whatever the reason for prescription

Sampling Method

Non-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

Not provided