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

Phase 4

Completed

• Conditions: Chronic Renal Insufficiency; Delivery Systems; Growth Hormone Deficiency in Children; Small for Gestational Age; Turner Syndrome; Chronic Kidney Disease; Growth Hormone Disorder; Foetal Growth Problem; Genetic Disorder
• Interventions: Device: Norditropin NordiFlex®

• Registration Number: NCT01245374
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-04-18
• Results First Submitted QC: 2012-05-22
• Results First Posted: 2012-06-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Children who can receive Norditropin® (somatropin) treatment according to the product labelling
• Treated with growth hormone for at least one year

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nordiflex Norditropin®	Norditropin NordiFlex®	Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)

Primary Outcome Measures

Name	Time	Method
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used	Week 6	Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.

Secondary Outcome Measures

Name	Time	Method
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products	Week 6	The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables.
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection	Week 6	The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.
Percentage of Participants Evaluating Simplicity of Use: Dose Modification	Week 6	The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness	Week 6	The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection	Week 6	The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training	Week 6	The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult).
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness	Week 6	The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Ease of Learning Assessed by the Physician or the Nurse: Time Learning	Week 6	The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour.
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment	Week 6	The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy.
Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial	Weeks 0 - 6

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Paris La défense cedex, France