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

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ClinicalTrials.gov Identifier: NCT01263457
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : December 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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™.

Condition or disease Intervention/treatment
Growth Disorders Device: 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 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

Study Type : Observational
Actual Enrollment : 191 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : November 30, 2010
Primary Completion Date : December 31, 2015
Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders
Drug Information available for: Somatropin
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Easypod
    Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod
    Other Names:
    • Saizen
    • Somatropin

Outcome Measures

Primary Outcome Measures :
  1. Mean percent of adherence by subject over a period of time [ Time Frame: At least 6 months and up to 5 years ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.
Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01263457     History of Changes
Other Study ID Numbers: EMR 200104-516
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: December 25, 2017
Last Verified: December 2017

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

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes