Text Size

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

This study is currently recruiting participants.
Verified April 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Gesellschaft mbH, Austria
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01296425
First received: February 14, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  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 hospitals in Austria and to assess the level of adherence of subjects 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 in Austria

Resource links provided by NLM:

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

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mean percent of adherence by subject [ 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 after each year of SAIZEN® treatment with Easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
    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™

  • 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: Yes ]
  • Correlation of adherence with current IGF-I status (i.e. above, below or within normal ranges) [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: July 2011
Estimated Primary Completion Date: September 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 Names:
    • Saizen
    • 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 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 identify adherence subject profiling
  • To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™
  • To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)
  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 device according to the Austrian Summary of Product Characteristics (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 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 another interventional clinical study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296425

Contacts
Contact: Merck KGaA Communication Center +49-6151-72-5200 service@merck.de

Locations
Austria
For Recruiting Recruiting
Locations in, Austria
Contact: Merck KGaA Communication Center     +49-6151-72-5200     service@merck.de    
Sponsors and Collaborators
Merck KGaA
Merck Gesellschaft mbH, Austria
Investigators
Study Director: Senior Medical Specialist Merck Gesellschaft mbH, Austria
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01296425     History of Changes
Other Study ID Numbers: EMR 200104-523
Study First Received: February 14, 2011
Last Updated: April 18, 2013
Health Authority: Austria: Agency for Health and Food Safety

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

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013