Clinical trial NCT01245374: Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 103
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
timeFrame: Week 6
measure: The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
timeFrame: Week 0
measure: Percentage of Participants Evaluating Simplicity of Use: Dose Modification
timeFrame: Week 0
measure: Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
timeFrame: Week 0
measure: Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
timeFrame: Week 0
measure: Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
timeFrame: Week 6
measure: Percentage of Participants Evaluating Simplicity of Use: Dose Modification
timeFrame: Week 6
measure: Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
timeFrame: Week 6
measure: Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
timeFrame: Week 6
measure: Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
timeFrame: Week 6
measure: Ease of Learning Assessed by the Physician or the Nurse: Time Learning
timeFrame: Week 6
measure: Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
timeFrame: Week 6
measure: Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
timeFrame: Week 0
measure: Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
timeFrame: Week 6
measure: Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
timeFrame: Week 6
measure: Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial
timeFrame: Weeks 0 - 6
Other outcomes:
Locations:
city: Paris La défense cedex
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Tauber M, Jaquet D, Jesuran-Perelroizen M, Petrus M, Bertrand AM, Coutant R; NordiFlex(R) French Study Group. User assessment of Norditropin NordiFlex((R)), a new prefilled growth hormone pen: a Phase IV multicenter prospective study. Patient Prefer Adherence. 2013 May 24;7:455-62. doi: 10.2147/PPA.S43460. Print 2013.