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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01309555




Registration number
NCT01309555
Ethics application status
Date submitted
3/03/2011
Date registered
7/03/2011
Date last updated
26/12/2017

Titles & IDs
Public title
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Australia
Scientific title
Easypod Connect: An Australian Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment
Secondary ID [1] 0 0
EMR 200104-521
Universal Trial Number (UTN)
Trial acronym
ECOS AUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth Disorders 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - easypod™

Treatment: Devices: easypod™
Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean percent of adherence by subject
Timepoint [1] 0 0
At least 6 months and up to 5 years
Secondary outcome [1] 0 0
Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™
Timepoint [1] 0 0
At least 6 months and up to 5 years
Secondary outcome [2] 0 0
Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment with easypod™
Timepoint [2] 0 0
At least 6 months and up to 5 years
Secondary outcome [3] 0 0
Correlation of adherence with current IGF-I status (i.e. above, below or within normal ranges)
Timepoint [3] 0 0
At least 6 months and up to 5 years

Eligibility
Key inclusion criteria
* Administered growth hormone via the easypod™ electromechanical device according to the SAIZEN® Product Information
* Aged between 2 and 18 years
* Appropriate Informed Consent/Assent provided
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with mature bone age taking growth hormone (i.e. for taking growth hormone for its metabolic effects)
* Contra-indications to SAIZEN® as defined in SAIZEN® Product Information
* Use of an investigational drug or participation in another interventional clinical trial

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2016
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
For Recruiting Locations in Australia - Please Contact The Merck KGaA Communication Center
Recruitment postcode(s) [1] 0 0
- Please Contact The Merck KGaA Communication Center

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Serono Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is an Australian, Multicentre, Observational Registry 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™.
Trial website
https://clinicaltrials.gov/study/NCT01309555
Trial related presentations / publications
Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.
Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Serono Australia Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01309555