NCT01267526

Brief Summary

This is a Canadian, 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 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
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

9 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

First Submitted

Initial submission to the registry

December 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

May 31, 2011

Completed
4.6 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

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

4.6 years

First QC Date

December 27, 2010

Last Update Submit

December 22, 2017

Conditions

Growth Disorders

Keywords

Growth disordersSaizenEasypodGrowth hormonePediatric subject

Outcome Measures

Primary Outcomes (1)

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

    Adherence will be defined as 86 percent adherent at one year based on prescribed therapy.

    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

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

    At least 6 months and up to 5 years

Interventions

Easypod™DEVICE

Saizen (Somatotropin) administered by easypod™ as defined in SAIZEN® Canadian Product Monograph

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

Pediatric subjects 18 and under who are prescribed SAIZEN® (Health Canada approved indications) using the easypod™ auto-injector.

You may qualify if:

  • Prescribed SAIZEN® via the easypod™ auto-injector (SAIZEN® Health Canadian approved indications: Growth Hormone Insufficiency or Deficiency, Turner's Syndrome, Chronic Renal Failure, Small for Gestational Age
  • Under 18 years of age, or over 18 without fusion of growth plates
  • Parent's or legal guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/legal 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 by Health Canada regulations. Adult consent is defined at 18+ in the province of Quebec, 16+ in the remainder of Canada.

You may not qualify if:

  • Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for its metabolic effects)
  • Contra-indications to SAIZEN® as defined in SAIZEN® Canadian Product Monograph.
  • Use of an investigational drug or participation in another interventional clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Merck Serono Research Site

Calgary, Alberta, Canada

Location

Merck Serono Research Site

Edmonton, Alberta, Canada

Location

Merck Serono Research Site

North Vancouver, British Columbia, Canada

Location

Merck Serono Research Site

Vancouver, British Columbia, Canada

Location

Merck Serono Research Site

Hamilton, Ontario, Canada

Location

Merck Serono Research Site

London, Ontario, Canada

Location

Merck Serono Research Site

Toronto, Ontario, Canada

Location

Merck Serono Research Site

Montreal, Quebec, Canada

Location

Merck Serono Research Site

Sherbrooke, Quebec, Canada

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

    EMD Serono, a division of EMD Inc., Canada

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 27, 2010

First Posted

December 28, 2010

Study Start

May 31, 2011

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

CA(9)