This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Merck Ltd., Taiwan
Information provided by (Responsible Party):
Merck KGaA Identifier:
First received: December 18, 2013
Last updated: August 9, 2016
Last verified: August 2016
This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment 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 Multinational, Multicentre, Observational Study to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "easypodTM" 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 2.5 years ]

Secondary Outcome Measures:
  • Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [ Time Frame: At least 6 months and up to 2.5 years ]
    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™

  • Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment [ Time Frame: At least 6 months and up to 2.5 years ]
  • Correlation of adherence with current IGF-1 status (that is, above, below or within normal ranges) [ Time Frame: At least 6 months and up to 2.5 years ]

Enrollment: 35
Study Start Date: February 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Growth Disorders Device: easypod™
Saizen® (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other Name: Somatropin

Detailed Description:

Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses 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 both 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 (IGF1) (that is, above, below or within normal ranges)

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

Inclusion Criteria:

  • Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristic (SmPC)
  • Over the age of 2 years
  • Under 18 years of age, or over 18 without fusion of growth plates
  • Parent's or guardian's written informed consent, given before entering data into the observational study, 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 (that is, 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 another 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: NCT02015273

For Recruiting Locations in Indonesia, Taiwan, Singapore please contact the Merck KGaA Communication Center
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA
Merck Ltd., Taiwan
Study Director: Medical Responsible Merck Ltd., Taiwan
  More Information

Responsible Party: Merck KGaA Identifier: NCT02015273     History of Changes
Other Study ID Numbers: 200104-540
Study First Received: December 18, 2013
Last Updated: August 9, 2016

Keywords provided by Merck KGaA:

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes processed this record on September 21, 2017