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Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00738205
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

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.


Study Design

Study Type : Observational
Actual Enrollment : 834 participants
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
Study Start Date : June 2007
Primary Completion Date : March 2009
Study Completion Date : June 2009


Groups and Cohorts

Group/Cohort
1
2


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen. [ Time Frame: week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Overall, 834 children using the electronic auto-injector were recruited. Of these, 824 children were included in the evaluable population. Of the 824 evaluable children, 601 were treatment-naïve and 223 were treatment-experienced.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738205


Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Clément Olivier, MD, LMCC Merck Serono S.A., Geneva
More Information

Publications:
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00738205     History of Changes
Other Study ID Numbers: Easypod
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Merck KGaA:
Electronic device
Growth hormone treatment

Additional relevant MeSH terms:
Renal Insufficiency
Dwarfism, Pituitary
Kidney Failure, Chronic
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Kidney Diseases
Urologic 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
Endocrine System Diseases
Renal Insufficiency, Chronic
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