NCT01376921

Brief Summary

This is a Spanish, 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™.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 30, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

June 17, 2011

Last Update Submit

December 22, 2017

Conditions

Growth Disorders

Keywords

Growth disordersSaizenEasypodGrowth hormonePediatric subject

Outcome Measures

Primary Outcomes (1)

  • Mean percent of daily recorded adherence

    At least 6 months and up to 5 years

Secondary Outcomes (3)

  • Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™

    At least 6 months and up to 5 years

  • Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment

    At least 6 months and up to 5 years

  • Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)

    At least 6 months and up to 5 years

Interventions

easypod™DEVICE

Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™

Also known as: Somatotropin

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.

You may qualify if:

  • Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristics (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 (16 years old) to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.

You may not qualify if:

  • 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 SmPC
  • Use of an investigational drug or participation in another interventional clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For Recruiting Locations in Spain

Please Contact the Merck KGaA Communication Center, Spain

Location

Related Publications (2)

  • 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.

    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.

    RESULT

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Merck, S.L., Spain

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 20, 2011

Study Start

September 30, 2012

Primary Completion

March 31, 2015

Study Completion

March 31, 2015

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

ES(1)