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 UsedThe Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Secondary outcome: Percentage of Participants Evaluating Simplicity of Use: Dose Selection EasinessPercentage 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
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