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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00738205
First received: August 19, 2008
Last updated: March 10, 2014
Last verified: March 2014

August 19, 2008
March 10, 2014
June 2007
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00738205 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Growth Hormone Deficiency
  • Turner Syndrome
  • Chronic Renal Failure
  • Small for Gestational Age
Not Provided
  • 1
  • 2
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. PubMed PMID: 21294891; PubMed Central PMCID: PMC3045978.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
834
June 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00738205
Easypod
Not Provided
Merck KGaA
Merck KGaA
Not Provided
Study Director: Clément Olivier, MD, LMCC Merck Serono S.A., Geneva
Merck KGaA
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP