Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-Injector - Full Text View

Purpose

This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.

Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.

Condition

Growth Hormone Deficiency
Turner Syndrome
Chronic Renal Failure
Small for Gestational Age

Genetics Home Reference related topics:

Turner syndrome

MedlinePlus related topics:

Growth Disorders Kidney Failure Turner Syndrome

ChemIDplus related topics:

Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-Injector When Administering Saizen® Growth Hormone to Children With Growth Disorders

Further study details as provided by EMD Serono:

Primary Outcome Measures:

To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children. [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen. [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	630
Study Start Date:	June 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

1

2

Detailed Description:

An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone.

The study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

315 Naïve patients & 315 experienced patients dissatisfied with their current device.

Criteria

Inclusion Criteria:

Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age [SGA] patients, based on RCP)

Exclusion Criteria:

Cases in which Saizen® is contra-indicated (based on local RCP)
Children returning for consultation, who have not brought back their Easypod™ electronic self-injector.
Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738205

Contacts


Contact: Monia Zignani, Pharm. D., Ph D.		monia.zignani@merckserono.net

Locations


Switzerland
	Local Medical Information	Recruiting
	Zug, Switzerland
	Contact: Local Medical Information +41-41-747-0812

Sponsors and Collaborators

EMD Serono

Investigators


Study Director:	Clément Olivier, MD, LMCC	Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

More Information

Responsible Party:	Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany ( Monia Zignani, Pharm. D., Ph D. )
Study ID Numbers:	Easypod
First Received:	August 19, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00738205
Health Authority:	Italy: Ethics Committee

Keywords provided by EMD Serono:

Electronic device

Growth hormone treatment

Study placed in the following topic categories:

Chromosomal abnormalities

Renal Insufficiency

Genital dwarfism

Gonadal Disorders

Kidney Failure, Chronic

Chromosome Disorders

Endocrine System Diseases

Growth hormone deficiency

Monosomy X

Turner Syndrome

Gonadal dysgenesis

Urogenital Abnormalities

Urologic Diseases

Genetic Diseases, Inborn

Renal Insufficiency, Chronic

Growth Disorders

Turner syndrome

Ovarian dwarfism

Endocrinopathy

Kidney Diseases

Congenital Abnormalities

Kidney Failure

Gonadal Dysgenesis

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Sex Chromosome Disorders

Sex Differentiation Disorders

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00738205