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

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

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

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-Injector When Administering Saizen® Growth Hormone to Children With Growth Disorders

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome combined pituitary hormone deficiency persistent Müllerian duct syndrome pseudoachondroplasia tetrasomy 18p Turner syndrome

MedlinePlus related topics: Growth Disorders Kidney Failure Turner Syndrome

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

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 ]

Estimated Enrollment:	630
Study Start Date:	June 2007
Study Completion Date:	June 2009
Primary Completion Date:	March 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

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Clément Olivier, MD, LMCC

Merck Serono S.A., Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

More Information

No publications provided

Responsible Party:	Monia Zignani, Pharm. D., Ph D., Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:	NCT00738205 History of Changes
Other Study ID Numbers:	Easypod
Study First Received:	August 19, 2008
Last Updated:	July 7, 2009
Health Authority:	Italy: Ethics Committee

Keywords provided by EMD Serono:

Electronic device
Growth hormone treatment

Additional relevant MeSH terms:

Dwarfism, Pituitary
Kidney Failure, Chronic
Renal Insufficiency
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders

ClinicalTrials.gov processed this record on February 09, 2012