ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01400984
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Merck spol. s r.o., Slovakia
Information provided by (Responsible Party):
Merck KGaA

Brief Summary:
This is a Slovakian, 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 or disease Intervention/treatment
Growth Disorders Device: easypod™

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)

Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Other
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 Slovakia
Actual Study Start Date : December 31, 2011
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

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


Intervention Details:
    Device: easypod™
    Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
    Other Name: Somatotropin


Primary Outcome Measures :
  1. Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 5 years ]

Secondary Outcome Measures :
  1. 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 ]
    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™

  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400984


Locations
Slovakia
For Recruiting Locations in Slovakia
Please Contact The Merck KGaA Communication Center, Slovakia
Sponsors and Collaborators
Merck KGaA
Merck spol. s r.o., Slovakia
Investigators
Study Director: Medical Director Merck spol. s r.o., Slovakia

Publications of Results:
Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.
Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01400984     History of Changes
Other Study ID Numbers: EMR200104-526
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

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

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes