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

Chronic Renal Failure Clinical Trial

Official title:

Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738205
• Other study ID #: Easypod
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: March 10, 2014
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Renal Failure
• Dwarfism, Pituitary
• Gonadal Dysgenesis
• Growth Hormone Deficiency
• Kidney Failure, Chronic
• Primary Ovarian Insufficiency
• Small for Gestational Age
• Turner Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.		week 12	No