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

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ClinicalTrials.gov Identifier: NCT01582334
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Merck Quimica Argentina S.A.I.C
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date April 19, 2012
First Posted Date April 20, 2012
Last Update Posted Date December 26, 2017
Actual Study Start Date March 31, 2013
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2012)
Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01582334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 19, 2012)
  • 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™
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina
Official Title Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Argentina
Brief Summary This is an Argentinian, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via 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 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) (i.e. above, below or within normal ranges)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.
Condition Growth Disorders
Intervention Device: easypod™
Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other Name: Somatropin
Study Groups/Cohorts Not Provided
Publications *
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 20, 2016)
68
Original Estimated Enrollment
 (submitted: April 19, 2012)
160
Actual Study Completion Date December 31, 2015
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility 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 (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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina
Removed Location Countries  
 
Administrative Information
NCT Number NCT01582334
Other Study ID Numbers EMR200104-532
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor Merck KGaA, Darmstadt, Germany
Collaborators Merck Quimica Argentina S.A.I.C
Investigators
Study Director: Medical Director Merck Quimica Argentina S.A.I.C
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date December 2017