Trial record 16 of 61 for:
Open Studies | "Growth Disorders"
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary (ECOS HUN)
This study is currently recruiting participants.
Verified September 2012 by Merck KGaA
Sponsor:
Merck KGaA
Collaborator:
Merck Kft., Hungary
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01402999
First received: July 22, 2011
Last updated: September 4, 2012
Last verified: September 2012
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Purpose
This is a Hungarian, Multicentre, Observational Study to study 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 Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment in Hungary |
Resource links provided by NLM:
MedlinePlus related topics:
Growth Disorders
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Merck KGaA:
Primary Outcome Measures:
- Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ 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 5 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 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 135 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: easypod™
Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
Other Name: Somatotropin
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 retrospectively and prospectively. This will allow the establishment of adherence profiles 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 Objective:
- To identify adherence subject profiling
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
- To asses the impact of adherence on Insulin-like Growth Factor-1 (IGF-1) (i.e. above, below or within normal ranges)
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.
Criteria
Inclusion Criteria:
- Administered growth hormone via the easypod™ electromechanical device according to the Summary of Product Characteristics (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.
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 an interventional clinical study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402999
Contacts
| Contact: Merck KGaA Communication Center | +49-6151-72-5200 | service@merck.de |
Locations
| Hungary | |
| For Recruiting Locations in Hungary | Recruiting |
| please contact the Merck KGaA Communication Center, Hungary | |
| Contact: Merck KGaA Communication Center +49-6151-72-5200 service@merck.de | |
Sponsors and Collaborators
Merck KGaA
Merck Kft., Hungary
Investigators
| Study Director: | Medical Director | Merck Kft., Hungary |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01402999 History of Changes |
| Other Study ID Numbers: | EMR200104-528 |
| Study First Received: | July 22, 2011 |
| Last Updated: | September 4, 2012 |
| Health Authority: | Hungary: Scientific and Medical Research Council Ethics Committee |
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 16, 2013