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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono Australia Pty Ltd
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01309555
First received: March 3, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

This is an Australian, 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: An Australian Multi-centre, 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 [ 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 with easypod™ [ 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: 83
Study Start Date: April 2011
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 (Somatropin) as per Summary of Product Characteristics administered by easypod™
    Other Name: 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 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) (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 SAIZEN® Product Information
  • Aged between 2 and 18 years
  • Appropriate Informed Consent/Assent provided

Exclusion Criteria:

  • Subjects with mature bone age taking growth hormone (i.e. for taking growth hormone for its metabolic effects)
  • Contra-indications to SAIZEN® as defined in SAIZEN® Product Information
  • Use of an investigational drug or participation in another 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: NCT01309555

Contacts
Contact: Medical Responsible +61 (0)2 8977 4150

Locations
Australia
For Recruiting Locations in Australia Recruiting
please contact the Merck KGaA Communication Center, Australia
Contact: Merck KGaA Communication Center    +49-6151-72-5200    service@merckgroup.com   
Sponsors and Collaborators
Merck KGaA
Merck Serono Australia Pty Ltd
Investigators
Principal Investigator: Peter Davies, Professor, MPhil, PhD School of Medicine, The University of Queensland
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01309555     History of Changes
Other Study ID Numbers: EMR 200104-521
Study First Received: March 3, 2011
Last Updated: July 10, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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 August 01, 2014