Trials / Completed
CompletedNCT01267526
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
"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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 205 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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™ .
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Easypod™ | Saizen (Somatotropin) administered by easypod™ as defined in SAIZEN® Canadian Product Monograph |
Timeline
- Start date
- 2011-05-31
- Primary completion
- 2015-12-31
- Completion
- 2015-12-31
- First posted
- 2010-12-28
- Last updated
- 2017-12-26
Locations
9 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT01267526. Inclusion in this directory is not an endorsement.