Completed

ECOS MEXEasypod 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

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What is being collected

Data Collection

Who is being recruted

Growth Disorders

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 2 to 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2012
See protocol details

Summary

Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 30, 2012

Actual date on which the first participant was enrolled.

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"

Official TitleEasypod 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
NCT01555528
Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

193 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Growth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate
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
Show More Criteria
3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

For Recruiting Locations in Mexico

Please Contact the Merck KGaA Communication Center, MexicoOpen For Recruiting Locations in Mexico in Google Maps
CompletedOne Study Center