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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01263457
First received: December 17, 2010
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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™.


Condition Intervention
Growth Disorders
Device: Easypod

Study Type: Observational
Study Design: Observational Model: Cohort
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mean percent of adherence by subject over a period of time [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Easypod
    Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod
    Other Names:
    • Saizen
    • Somatropin
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 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
  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263457

Locations
United Kingdom
Merck Serono Research Site
Sutton, Surrey, United Kingdom, SM2 5PT
Merck Serono Research Site
Birmingham, West Midlands, United Kingdom, B4 6NH
Merck Serono Research Site
Glasgow, United Kingdom, G3 8SJ
Merck Serono Research Site
Hull, United Kingdom, HU3 2JZ
Merck Serono Research Site
London, United Kingdom, WC1N 1EH
Merck Serono Research Site
Sheffield, United Kingdom, S10 2TH
Sponsors and Collaborators
Merck KGaA
Merck Serono Limited, UK
Investigators
Study Director: Medical Responsible Merck Serono Limited, UK
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01263457     History of Changes
Other Study ID Numbers: EMR 200104-516
Study First Received: December 17, 2010
Last Updated: August 1, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Merck KGaA:
Growth disorders
Saizen
EasypodTM
Growth hormone
Pediatric subject

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014