Trial record 14 of 66 for:    Open Studies | "Growth Disorders"

To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East (ECOS UAE)

This study is not yet open for participant recruitment.
Verified January 2014 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono Middle East FZ LLC
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT02015286
First received: December 12, 2013
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

This is a Middle East, 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 Regional, Multicentre, Observational Study to Evaluate 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 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 (that is, above, below or within normal ranges) [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: March 2016
Estimated 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)
  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

Pediatric 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02015286

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

Locations
Germany
For Recruiting Locations in the United Arab Emirates and the Kingdom of Saudi Arabia Not yet recruiting
please contact the Merck KGaA Communication Center located in, Darmstadt, Germany
Contact: Merck KGaA Communication Center    +49-6151-72-5200    service@merckgroup.com   
Sponsors and Collaborators
Merck KGaA
Merck Serono Middle East FZ LLC
Investigators
Study Director: Medical Responsible Merck Serono Middle East FZ LLC
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT02015286     History of Changes
Other Study ID Numbers: EMR 200104-534
Study First Received: December 12, 2013
Last Updated: January 14, 2014
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi

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 23, 2014