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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

834 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

2

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No