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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01327924

Collaborator

(none)

Enrollment

Location

Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Genetic Disorder Turner Syndrome Foetal Growth Problem Small for Gestational Age Chronic Kidney Disease Chronic Renal Insufficiency Delivery Systems	Drug: Norditropin NordiFlex®

Study Design

Study Type:

Observational

Actual Enrollment :

77 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Norditropin NordiFlex® users	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.

Arm

Intervention/Treatment

Norditropin NordiFlex® users

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.

Outcome Measures

Primary Outcome Measures

Usability of growth hormone injection device assessed by a quantitative scale [after 3 months of growth hormone treatment]

Secondary Outcome Measures

Number of adverse events [from 0 - 3 months of growth hormone treatment]
Number of technical complaints [from 0 to 3 months of growth hormone treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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