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

This study is ongoing, but not recruiting participants.
Merck A.B., Sweden
Information provided by (Responsible Party):
Merck KGaA Identifier:
First received: March 1, 2011
Last updated: March 3, 2015
Last verified: March 2015

This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment 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 Swedish, 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 daily recorded adherence [ 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 (change in height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(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 ]
  • Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
  • Correlation of adherence and HbA1C [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 159
Study Start Date: June 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: easypod™
    Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
    Other Name: Somatotropin
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 population-based 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 based on age, gender, self injection or not, time on treatment, medical history at time of enrollment
  • To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Other Objectives:

• To assess the impact of adherence on average blood glucose (HbA1C)


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.


Inclusion Criteria:

  • Administered growth hormone via the EasypodTM electromechanical device according to Summary of Product Characteristics (SmPC)
  • Over the age of > 2 years old
  • Under < 18 years of age, or over 18 years of age without fusion of growth plates
  • Parent's or guardian's written informed consent, given before entering data into the registry , with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.

Exclusion Criteria:

  • Subjects 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
  • Use of an investigational drug or participation in an interventional clinical study
  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 identifier: NCT01307059

Merck Serono Research Site
Göteborg, Sweden
Merck Serono Research Site
Solna, Sweden
Merck Serono Research Site
Uppsala, Sweden
Sponsors and Collaborators
Merck KGaA
Merck A.B., Sweden
Study Director: Medical Responsible Merck A.B., Sweden
  More Information

No publications provided

Responsible Party: Merck KGaA Identifier: NCT01307059     History of Changes
Other Study ID Numbers: EMR 200104-524
Study First Received: March 1, 2011
Last Updated: March 3, 2015
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes processed this record on March 26, 2015