Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
1 other identifier
observational
834
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 11, 2014
March 1, 2014
1.8 years
August 19, 2008
March 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
week 12
Secondary Outcomes (1)
To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.
week 12
Study Arms (2)
1
2
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Bozzola M, Colle M, Halldin-Stenlid M, Larroque S, Zignani M; easypod survey study group. Treatment adherence with the easypod growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents. BMC Endocr Disord. 2011 Feb 4;11:4. doi: 10.1186/1472-6823-11-4.
PMID: 21294891RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clément Olivier, MD, LMCC
Merck Serono S.A., Geneva
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 20, 2008
Study Start
June 1, 2007
Primary Completion
March 1, 2009
Study Completion
June 1, 2009
Last Updated
March 11, 2014
Record last verified: 2014-03