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A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment — ECOS CAN  

Growth Disorders Clinical Trial

Official title:
"Easypod™ Connect Registry": A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of SAIZEN® in Pediatric Subjects Using Easypod™ Auto-injector

Clinical Trial Summary

This is a Canadian, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospital and to assess the level of adherence of subject receiving SAIZEN® via Easypod™ .

Clinical Trial Description

Subjects will be enrolled in a multicenter, longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the Easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

- To assess the level of adherence of subjects prescribed SAIZEN® via easypod™

Secondary Objectives:

- To describe the impact of adherence on clinical outcomes for subject prescribed SAIZEN via easypod™

- To identify adherence subject profiling ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01267526
Study type Observational
Source Merck KGaA
Contact
Status Completed
Phase N/A
Start date May 31, 2011
Completion date December 31, 2015
View Details
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