Skip to main content
OpenTrials
Completed

NCT Number: NCT01263457

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

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™.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Sutton, Surrey, United Kingdom

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Administered growth hormone via the easypod electromechanical injection device according to Summary of Product Characteristics (SmPC)
  • Over the age of 2 years
  • Under 18 years of age, or over 18 without fusion of growth plates (to be confirmed by the Investigator, where relevant)
  • Appropriate Informed Consent/Assent provided

Exclusion criteria

  • Patients taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
  • Contra-indications to Saizen as defined in the SmPC or any other condition which precludes the use of SAIZEN in a given patient
  • Use of an investigational drug or participation in an interventional clinical trial

Treatment and study plan

Easypod

Device

Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod

Other names: Saizen, Somatropin

Primary outcomes

  1. Mean percent of adherence by subject over a period of time

    Time frame: At least 6 months and up to 5 years

Secondary outcomes

  1. Correlation of adherence and growth outcome (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, change in height (height SDS) after each year of SAIZEN® treatment with easypod™

    Time frame: At least 6 months and up to 5 years

  2. Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment

    Time frame: At least 6 months and up to 5 years

  3. Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™

    Time frame: At least 6 months and up to 5 years

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Limited, UK

Registry information

Official study 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

Acronym: ECOS UK

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 20, 2010
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.