Trial record 16 of 66 for:    Open Studies | "Growth Disorders"

Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic (ECOS CZ)

This study is currently recruiting participants.
Verified December 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck spol.s.r.o., Czech Republic
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01400997
First received: July 21, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

This is Multicentre, Observational Study 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 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 Czech Republic

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 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 (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 5 years ] [ Designated as safety issue: Yes ]
  • 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: Yes ]

Estimated Enrollment: 140
Study Start Date: September 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: easypod™
    Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
    Other Name: Somatotropin
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 retrospectively and prospectively. This will allow the establishment of adherence profiles 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 Objective:

  • 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 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 observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400997

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

Locations
Czech Republic
For Recruiting Locations in Czech Republic Recruiting
please contact the Merck KGaA Communication Center, Czech Republic
Contact: Merck KGaA Communication Center    +49-6151-72-5200    service@merckgroup.com   
Sponsors and Collaborators
Merck KGaA
Merck spol.s.r.o., Czech Republic
Investigators
Study Director: Medical Director Merck spol.s.r.o., Czech Republic
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01400997     History of Changes
Other Study ID Numbers: EMR200104-527
Study First Received: July 21, 2011
Last Updated: December 12, 2013
Health Authority: Czech Republic: State Institute for Drug Control

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 April 14, 2014