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Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Foetal Growth Problem; Small for Gestational Age; Genetic Disorder; Turner Syndrome; Chronic Kidney Disease; Chronic Renal Insufficiency; Delivery Systems

Intervention: Norditropin NordiFlex® (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Delphine Jaquet, Study Director, Affiliation: Novo Nordisk Pharmaceutique S.A.S

Summary

This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex device to the device previously used by patients or parents.

Clinical Details

Official title: Assessment of the Ease of Use of Norditropin NordiFlex Relative to the One of the Device Previously Used by Patients or Parents

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used

The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used

Secondary outcome:

Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness

Percentage of Participants Evaluating Simplicity of Use: Dose Modification

Percentage of Participants Evaluating Simplicity of Use: Injection Easiness

Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection

Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness

Percentage of Participants Evaluating Simplicity of Use: Dose Modification

Percentage of Participants Evaluating Simplicity of Use: Injection Easiness

Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection

Ease of Learning Assessed by the Physician or the Nurse: Ease of Training

Ease of Learning Assessed by the Physician or the Nurse: Time Learning

Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products

Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection

Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection

Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment

Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial

Eligibility

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children who can receive Norditropin® (somatropin) treatment according to the product

labelling

- Treated with growth hormone for at least one year

Exclusion Criteria:

- Contraindications to Norditropin® growth hormone therapy

- Known or suspected hypersensitivity to somatropin or related products

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

start

- Life threatening disease, for example cancer

- Pregnancy or the intention of becoming pregnant

Locations and Contacts

Paris La défense cedex 92932, France
Additional Information

Clinical Trials at Novo Nordisk

Starting date: November 2010
Last updated: October 19, 2012

Page last updated: August 23, 2015

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