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To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Columbia — ECOS COL  

Growth Disorders Clinical Trial

Official title:
Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Columbia

Clinical Trial Summary

This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment 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 study. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses 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 both 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 receiving SAIZEN® via easypod™

Secondary Objectives:

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

- To identify adherence subject profiling

- To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02208076
Study type Observational
Source Merck KGaA
Contact
Status Completed
Phase N/A
Start date July 31, 2014
Completion date December 31, 2015
View Details
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