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

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ClinicalTrials.gov Identifier: NCT01245374
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : June 25, 2012
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE November 19, 2010
First Posted Date  ICMJE November 22, 2010
Results First Submitted Date  ICMJE April 18, 2012
Results First Posted Date  ICMJE June 25, 2012
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE November 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2012)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
  • The ease of injection using Norditropin NordiFlex® compared to the device previously used measured by a quantative scale [ Time Frame: Week 6 ]
  • Patient autonomy measured by the number of operations performed by the patient and the proportion of patients achieving all of these operations in comparison to the device previously used [ Time Frame: Week 6 ]
Change History Complete list of historical versions of study NCT01245374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2012)
  • 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).
  • 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).
  • 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).
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
  • Easiness of training of Norditropin NordiFlex® using a Likert scale [ Time Frame: Week 6 ]
  • Proportion of patients wishing to continue treatment with Norditropin NordiFlex® over any other system [ Time Frame: Week 6 ]
  • Clinical and technical safety of Norditropin NordiFlex® by recording adverse events, medical events of special interest (MESI) and technical problems [ Time Frame: Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
Official Title  ICMJE Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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  ICMJE 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
Study Arms  ICMJE 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)
Intervention: Device: Norditropin NordiFlex®
Publications * Tauber M, Jaquet D, Jesuran-Perelroizen M, Petrus M, Bertrand AM, Coutant R; NordiFlex® French Study Group. User assessment of Norditropin NordiFlex(®), 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. Erratum in: Patient Prefer Adherence. 2013 Aug 19;7:803.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2011)
103
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2010)
200
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01245374
Other Study ID Numbers  ICMJE GH-3826
U1111-1117-1194 ( Other Identifier: WHO )
2009-017387-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP