NCT01263457

Brief 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 hospital in the UK and 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
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

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

Study Start

First participant enrolled

November 30, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

5.1 years

First QC Date

December 17, 2010

Last Update Submit

May 4, 2021

Conditions

Growth Disorders

Keywords

Growth disordersSaizenEasypodTMGrowth hormonePediatric subject

Outcome Measures

Primary Outcomes (1)

  • Mean percent of adherence by subject over a period of time

    At least 6 months and up to 5 years

Secondary Outcomes (3)

  • 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™

    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

  • Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™

    At least 6 months and up to 5 years

Interventions

EasypodDEVICE

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

Also known as: Saizen, Somatropin

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 injection 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 (to be confirmed by the Investigator, where relevant)
  • Appropriate Informed Consent/Assent provided

You may not qualify if:

  • Patients 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 or any other condition which precludes the use of SAIZEN in a given patient
  • Use of an investigational drug or participation in an interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Research Site

Birmingham, West Midlands, B4 6NH, United Kingdom

Location

Research Site

Glasgow, G3 8SJ, United Kingdom

Location

Research Site

Hull, HU3 2JZ, United Kingdom

Location

Research Site

London, WC1N 1EH, United Kingdom

Location

Research Site

Sheffield, S10 2TH, United Kingdom

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 Responsible

    Merck Serono Limited, UK

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 20, 2010

Study Start

November 30, 2010

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

May 5, 2021

Record last verified: 2021-05

Locations

GB(6)