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

January 12, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris La défense cedex, France, 92932
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nordiflex Norditropin®
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)
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Time Frame: Week 6
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
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Time Frame: 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.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Time Frame: Week 0
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
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Time Frame: Week 0
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
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Time Frame: Week 0
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
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Time Frame: Week 0
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
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Time Frame: 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).
Week 6
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Time Frame: 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).
Week 6
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Time Frame: 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).
Week 6
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Time Frame: 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.
Week 6
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
Time Frame: 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).
Week 6
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
Time Frame: 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.
Week 6
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Time Frame: 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.
Week 6
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Time Frame: Week 0
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
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Time Frame: 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.
Week 6
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
Time Frame: 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.
Week 6
Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial
Time Frame: Weeks 0 - 6
Weeks 0 - 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-3826
  • U1111-1117-1194 (Other Identifier: WHO)
  • 2009-017387-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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