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To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East

NCT ID: NCT02015286

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

Brief Summary

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This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Detailed Description

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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 both retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence 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 assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (that is, above, below or within normal ranges)

Conditions

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Growth Disorders

Keywords

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Growth disorders Saizen Easypod Growth hormone Pediatric subject

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Growth Disorders

easypod™

Intervention Type DEVICE

Saizen® (Somatropin) as per Summary of Product Characteristics administered by easypod™

Interventions

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easypod™

Saizen® (Somatropin) as per Summary of Product Characteristics administered by easypod™

Intervention Type DEVICE

Other Intervention Names

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Somatropin

Eligibility Criteria

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Inclusion Criteria

* Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristic (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. If the child is old enough 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 (that is, 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 another interventional clinical study
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono Middle East FZ LLC

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono Middle East FZ LLC

Locations

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For Recruiting Locations in the United Arab Emirates and the Kingdom of Saudi Arabia

Please Contact the Merck KGaA Communication Center, Darmstadt, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT

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.

Reference Type RESULT

Other Identifiers

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EMR 200104-534

Identifier Type: -

Identifier Source: org_study_id