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

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ClinicalTrials.gov Identifier: NCT01555528
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Merck S.A. de C.V., Mexico
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date March 13, 2012
First Posted Date March 15, 2012
Last Update Posted Date December 26, 2017
Actual Study Start Date April 30, 2012
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2012)
Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 4 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01555528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2012)
  • Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [ Time Frame: At least 6 months and up to 4 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 4 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 4 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 Mexico
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 Mexico
Brief Summary This is a Mexican, Multicentre, Observational Study to evaluate 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™.
Detailed Description

Subjects will be enrolled in a multicenter longitudinal observational study. Parents and patients will provide their Informed Consent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program "AUMENTA" 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
  • To asses the impact of adherence on IGF1 (i.e. above, below or within normal ranges)
  • To assess/describe the impact of Mexico patient support program "AUMENTA"
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 (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Other Name: Somatotropin
Study Groups/Cohorts Growth Disorders
Intervention: Device: easypod™
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: March 3, 2015)
193
Original Estimated Enrollment
 (submitted: March 14, 2012)
192
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 local Prescribing information
  • Over the age of > 2 years
  • Under < 18 years of age, or over 18 without fusion of growth plates
  • Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given
  • Patient signed informed consent if has 7-17 years old
  • Patient signed informed consent if has 18 years old

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 local prescribing information
  • 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 Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT01555528
Other Study ID Numbers EMR200104_535
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 S.A. de C.V., Mexico
Investigators
Study Director: Medical Director Merck S.A. de C.V., Mexico, an affiliate of Merck KGaA, Darmstadt,
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date December 2017