Trial record 4 of 61 for:
Open Studies | "Growth Disorders"
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ Electromechanical Device for Growth Hormone Treatment (ECOS CHN)
This study is currently recruiting participants.
Verified April 2012 by Merck KGaA
Sponsor:
Merck KGaA
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01438528
First received: September 20, 2011
Last updated: April 3, 2012
Last verified: April 2012
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Purpose
This is a Chinese, 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 Time Perspective: Prospective |
| Official Title: | Easypod Connect: A National, Multicentre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "easypodTM" Electromechanical Device for Growth Hormone Treatment in China |
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: | 100 |
| Study Start Date: | December 2011 |
| 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 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 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 Insulin-like Growth Factor 1 (IGF1) (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:
- Over the age of >2 years
- Under <18 years of age, or over 18 without fusion of growth plates
- Patients diagnosed with growth hormone deficiency
- Naïve to growth hormone treatment
- 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 (16 years old) 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 Summary of Product Characteristics (SmPC)
- Use of an investigational drug or participation in another interventional clinical study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438528
Contacts
| Contact: Merck KGaA Communication Center | +49-6151-72-5200 | service@merck.de |
Locations
| China | |
| For Recruiting Locations in China | Recruiting |
| please contact the Merck KGaA Communication Center, China | |
| Contact: Merck KGaA Communication Center +49-6151-72-5200 service@merck.de | |
Sponsors and Collaborators
Merck KGaA
Merck Serono Co., Ltd., China
Investigators
| Study Director: | Medical Director | Merck Serono China |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01438528 History of Changes |
| Other Study ID Numbers: | EMR200104-530 |
| Study First Received: | September 20, 2011 |
| Last Updated: | April 3, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Merck KGaA:
|
Growth disorders Saizen Easypod Growth hormone Pediatric subject |
Additional relevant MeSH terms:
|
Growth Disorders Pathologic Processes Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013