A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment (ECOS CAN)
This study is currently recruiting participants.
Verified August 2012 by Merck KGaA
Sponsor:
Merck KGaA
Collaborator:
EMD Serono, a division of EMD Inc., Canada
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01267526
First received: December 27, 2010
Last updated: August 27, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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™ .
| Condition | Intervention |
|---|---|
|
Growth Disorders |
Device: Easypod™ |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | "Easypod™ Connect Registry": A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of SAIZEN® in Pediatric Subjects Using Easypod™ Auto-injector |
Resource links provided by NLM:
MedlinePlus related topics:
Growth Disorders
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Merck KGaA:
Primary Outcome Measures:
- Mean percent of adherence by subject over a period of time [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]Adherence will be defined as 86 percent adherent at one year based on prescribed therapy.
Secondary Outcome Measures:
- Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]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™
- Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
- Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 153 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: Easypod™
- Saizen
- Somatropin
Saizen (Somatotropin) administered by easypod™ as defined in SAIZEN® Canadian Product Monograph
Other Names:
Subjects will be enrolled in a multicenter, longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence 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 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 prescribed SAIZEN® via easypod™
Secondary Objectives:
- To describe the impact of adherence on clinical outcomes for subject prescribed SAIZEN via easypod™
- To identify adherence subject profiling
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric subjects 18 and under who are prescribed SAIZEN® (Health Canada approved indications) using the easypod™ auto-injector.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267526
Contacts
| Contact: Patrick Moriarty, PhD | 1-888-737-6668 ext 5203 |
Locations
| Canada, Alberta | |
| Merck Serono Research Site | Recruiting |
| Calgary, Alberta, Canada | |
| Merck Serono Research Site | Not yet recruiting |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| Merck Serono Research Site | Not yet recruiting |
| North Vancouver, British Columbia, Canada | |
| Merck Serono Research Site | Recruiting |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Merck Serono Research Site | Recruiting |
| Hamilton, Ontario, Canada | |
| Merck Serono Research Site | Recruiting |
| London, Ontario, Canada | |
| Merck Serono Research Site | Recruiting |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Merck Serono Research Site | Recruiting |
| Montréal, Quebec, Canada | |
| Merck Serono Research Site | Not yet recruiting |
| Montréal, Quebec, Canada | |
| Merck Serono Research Site | Not yet recruiting |
| Sherbrooke, Quebec, Canada | |
Sponsors and Collaborators
Merck KGaA
EMD Serono, a division of EMD Inc., Canada
Investigators
| Study Director: | Patrick Moriarty, PhD | EMD Serono, a division of EMD Inc., Canada |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01267526 History of Changes |
| Other Study ID Numbers: | EMR200104-517 |
| Study First Received: | December 27, 2010 |
| Last Updated: | August 27, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Merck KGaA:
|
Growth disorders Saizen Easypod Growth hormone Pediatric subject |
Additional relevant MeSH terms:
|
Growth Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013