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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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™ - Correlation of adherence and growth outcome (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, change in height (height SDS) 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT01309555
Trial related presentations / publications
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
Other publications