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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Norditropin NordiFlex® users

Norditropin NordiFlex®

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No