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

Growth Disorders Clinical Trial

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

Clinical Trial Summary

This is a National, 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 in the UK 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 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 (IGF-1) (i.e. above, below or within normal ranges) - To assess the endocrinological profile including Triiodothyronine (T3), Thyroxine (T4), Thyroid-stimulating hormone (TSH), Insulin-like Growth Factor 1 (IGF-1) and Insulin-like Growth Factor-Binding Protein 3(IGFBP-3) levels - Temporal profile of IGF-1 and IGFBP-3 levels ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01263457
Study type Observational
Source Merck KGaA, Darmstadt, Germany
Contact
Status Completed
Phase
Start date November 30, 2010
Completion date December 31, 2015
View Details
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