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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245374
• Other study ID #: GH-3826
• Secondary ID: U1111-1117-11942
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2010
• Last updated: October 19, 2012
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: October 2012
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Renal Insufficiency
• Delivery Systems
• Disease
• Dwarfism, Pituitary
• Foetal Growth Problem
• Genetic Disorder
• Gonadal Dysgenesis
• Growth Hormone Deficiency in Children
• Growth Hormone Disorder
• Kidney Diseases
• Primary Ovarian Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Small for Gestational Age
• Turner Syndrome

Intervention

Drug:
• Norditropin NordiFlex®
Daily administration by a subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used	Analysed for the ITT (intent-to-treat) 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.	Week 6	No
Primary	The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used	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.	Week 6	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness	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).	Week 0	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Dose Modification	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).	Week 0	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Injection Easiness	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).	Week 0	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection	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.	Week 0	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness	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).	Week 6	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Dose Modification	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).	Week 6	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Injection Easiness	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).	Week 6	No
Secondary	Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection	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.	Week 6	No
Secondary	Ease of Learning Assessed by the Physician or the Nurse: Ease of Training	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).	Week 6	No
Secondary	Ease of Learning Assessed by the Physician or the Nurse: Time Learning	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.	Week 6	No
Secondary	Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products	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.	Week 6	No
Secondary	Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection	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.	Week 0	No
Secondary	Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection	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.	Week 6	No
Secondary	Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment	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.	Week 6	No
Secondary	Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial		Weeks 0 - 6	No

External Links

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