To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Mexico (ECOS MEX)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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™.
| Condition | Intervention |
|---|---|
|
Growth Disorders |
Device: easypod™ |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| 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 |
- Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 4 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 192 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Growth Disorders |
Device: easypod™
Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Other Name: Somatotropin
|
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"
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.
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
Contacts and Locations| Contact: Merck KGaA Communication Center | +49-6151-72-5200 | service@merck.de |
| Mexico | |
| For Recruiting Locations in Mexico | Recruiting |
| please contact the Merck KGaA Communication Center, Mexico | |
| Contact: Merck KGaA Communication Center +49-6151-72-5200 service@merck.de | |
| Study Director: | Medical Director | Merck S.A. de C.V., Mexico, an affiliate of Merck KGaA, Darmstadt, |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01555528 History of Changes |
| Other Study ID Numbers: | EMR200104_535 |
| Study First Received: | March 13, 2012 |
| Last Updated: | September 7, 2012 |
| Health Authority: | Mexico: Secretaria de Salud |
Keywords provided by Merck KGaA:
|
Growth disorders Saizen Easypod Growth hormone Pediatric subject |
Additional relevant MeSH terms:
|
Growth Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013