Growth DisordersECOS FRANCT01291394
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France
An observational study of Growth Disorders, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
Trial summary
This is 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 from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Growth Disorders
- What is being tested?
- Easypod™
- Type of treatment
- Medical device
- How many people
- 223 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2011to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects who are taking SAIZEN® for a pediatric registered indications using the Easypod™ electromechanical device.
Who may be able to join
- Administered Saizen® via the Easypod™ electromechanical device according to pediatric registered indications (Growth Hormone Deficiency, Small for Gestational Age, Turner-Syndrome or prepubertal children with Chronic Renal Failure).
- Naïve subjects or already treated with Saizen and Easypod for maximum 1 year
- Male and Female between 2 - 18 years of age, or over 18 without fusion of growth plates
- Parent's or guardian's (or subject if over 18 without fusion of growth plates) written agreement, given before entering data into the study, with the understanding that the subject or parent/guardian may withdraw agreement at any time without prejudice to future medical care.
Who cannot join
- Subjects taking Saizen® in whom growth plates have fused (i.e. taking growth hormone for it's metabolic effects)
- Contra-indications to Saizen® as defined in the French Summary of Product Characteristics (SmPC)
- Use of an investigational drug or participation in an interventional clinical study
Trial locations and contacts
1 site in 1 country.
About this study
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
This is 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 from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.
Read the detailed description
Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF.
Easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height \& weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes.
Since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device 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) ranges/levels
- Conditions
- Growth Disorders
- Being tested
- Easypod™
- Keywords
- Growth disorders, Saizen, Easypod, Growth hormone, Pediatric subject
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Easypod™Device
Also called Somatotropin
Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent of recorded adherence
Measured: At least 6 months and up to 5 years
Secondary outcomes (3)
Correlation of adherence and growth outcome (change in height velocity (HV), change in HV-Standard Deviation Score (HV-SDS), change in height-Standard Deviation Score) after each year of Saizen® treatment with Easypod™
Measured: At least 6 months and up to 5 years
Subject adherence profile
Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment, administration regimen (6 or 7 days/ week), combination of pituitary hormone deficiencies, previous and/or concomitant treatments, socio-economic data
Measured: At least 6 months and up to 5 years
Correlation of adherence with IGF-1 levels/ranges
Measured: At least 6 months and up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study start31 Jan 2011
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Growth DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A.S, France
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, MGS Division, Merck Serono s.a.s, France, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291394
- Sponsor's protocol ID
- EMR 200104-515
- Acronym
- ECOS FRA
- Status last verified
- Dec 2017
- First submitted
- 31 Jan 2011
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01291394
- Acronym / sponsor ID
- ECOS FRA / EMR 200104-515
- Conditions
- Growth Disorders
- Keywords
- Growth disorders, Saizen, Easypod, Growth hormone, Pediatric subject
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A.S, France
- Study start
- 31 Jan 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is 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 from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.
Detailed description
Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF.
Easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height \& weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes.
Since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device 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) ranges/levels
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects who are taking SAIZEN® for a pediatric registered indications using the Easypod™ electromechanical device.
Key inclusion criteria (4 listed)
- Administered Saizen® via the Easypod™ electromechanical device according to pediatric registered indications (Growth Hormone Deficiency, Small for Gestational Age, Turner-Syndrome or prepubertal children with Chronic Renal Failure).
- Naïve subjects or already treated with Saizen and Easypod for maximum 1 year
- Male and Female between 2 - 18 years of age, or over 18 without fusion of growth plates
- Parent's or guardian's (or subject if over 18 without fusion of growth plates) written agreement, given before entering data into the study, with the understanding that the subject or parent/guardian may withdraw agreement at any time without prejudice to future medical care.
Key exclusion criteria (3 listed)
- Subjects taking Saizen® in whom growth plates have fused (i.e. taking growth hormone for it's metabolic effects)
- Contra-indications to Saizen® as defined in the French Summary of Product Characteristics (SmPC)
- Use of an investigational drug or participation in an interventional clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Easypod™Also: SomatotropinSaizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™ | Device | – |
Primary outcome
Mean percent of recorded adherence
Time frame: At least 6 months and up to 5 years
3 secondary outcomes
Correlation of adherence and growth outcome (change in height velocity (HV), change in HV-Standard Deviation Score (HV-SDS), change in height-Standard Deviation Score) after each year of Saizen® treatment with Easypod™
Time frame: At least 6 months and up to 5 years
Subject adherence profile
Time frame: At least 6 months and up to 5 years
Correlation of adherence with IGF-1 levels/ranges
Time frame: At least 6 months and up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Results publicationKoledova, 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.
- Results publicationWit, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
MGS Division, Merck Serono s.a.s, France, an affiliate of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Disorders, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent of recorded adherence (time frame: At least 6 months and up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291394, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.