To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina (ECOS ARG)
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| ClinicalTrials.gov Identifier: NCT01582334 |
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Recruitment Status :
Completed
First Posted : April 20, 2012
Last Update Posted : December 26, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Growth Disorders | Device: easypod™ |
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 |
| Actual Enrollment : | 68 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| 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 |
| Actual Study Start Date : | March 31, 2013 |
| Actual Primary Completion Date : | December 31, 2015 |
| Actual Study Completion Date : | December 31, 2015 |
- Device: easypod™
Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™Other Name: Somatropin
- Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 5 years ]
- 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 ]
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| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582334
| Argentina | |
| For Recruiting Locations in Argentina | |
| Please Contact The Merck KGaA Communication Center, Argentina | |
| Study Director: | Medical Director | Merck Quimica Argentina S.A.I.C |
Publications of Results:
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01582334 History of Changes |
| Other Study ID Numbers: |
EMR200104-532 |
| First Posted: | April 20, 2012 Key Record Dates |
| Last Update Posted: | December 26, 2017 |
| Last Verified: | December 2017 |
Keywords provided by Merck KGaA:
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Growth disorders Saizen Easypod Growth hormone Pediatric subject |
Additional relevant MeSH terms:
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Growth Disorders Pathologic Processes |