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

March 10, 2014 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Clément Olivier, MD, LMCC, Merck Serono S.A., Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Easypod

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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