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NCT01327924 Clinical Trial

Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone

Chronic Kidney Disease Clinical Trial

Official title:
Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01327924
Other study ID # GH-3870
Secondary ID U1111-1119-8619
Status Completed
Phase N/A
First received March 31, 2011
Last updated June 23, 2014
Start date April 2011
Est. completion date June 2012

Study information
Verified date June 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility Inclusion Criteria:

- Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study

- Subjects who receive Norditropin NordiFlex® according to the SPC

Exclusion Criteria:

- Known or suspected allergy to study product(s) or related products

- Child and/or parent unable to give consent or fill out the questionnaires

- The receipt of any investigational medicinal product within 3 months prior to this study

- Suffer from a life-threatening disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Norditropin NordiFlex®
Daily administration by subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Usability of growth hormone injection device assessed by a quantitative scale after 3 months of growth hormone treatment No
Secondary Number of adverse events from 0 - 3 months of growth hormone treatment No
Secondary Number of technical complaints from 0 to 3 months of growth hormone treatment No
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