To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Mexico

Growth Disorders Clinical Trial

— ECOS MEX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555528
• Other study ID #: EMR200104_535
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: December 22, 2017
• Start date: April 30, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: December 2017
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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™.

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"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth Disorders

Intervention

Device:
• easypod™
Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™

Locations

Country	Name	City	State
Mexico	For Recruiting Locations in Mexico	Please Contact The Merck KGaA Communication Center

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck S.A. de C.V., Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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 Interna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent of daily recorded adherence		At least 6 months and up to 4 years
Secondary	Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™	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™	At least 6 months and up to 4 years
Secondary	Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment		At least 6 months and up to 4 years
Secondary	Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)		At least 6 months and up to 4 years