Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-Injector
Information source: EMD Serono
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency; Turner Syndrome; Chronic Renal Failure; Small for Gestational Age
Phase: N/A
Status: Recruiting
Sponsored by: EMD Serono Official(s) and/or principal investigator(s):
Clément Olivier, MD, LMCC, Study Director, Affiliation: Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
Overall contact:
Monia Zignani, Pharm. D., Ph D., Email: monia.zignani@merckserono.net
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.
Clinical Details
Official title: Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-Injector When Administering Saizen® Growth Hormone to Children With Growth Disorders
Study design: Cohort, Prospective
Primary outcome: 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.
Secondary outcome: To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.
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
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Monia Zignani, Pharm. D., Ph D., Email: monia.zignani@merckserono.net
Local Medical Information, Zug, Switzerland; Recruiting
Local Medical Information, Phone: +41-41-747-0812
Additional Information
Starting date: June 2007
Ending date: September 2009
Last updated: September 2, 2008
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