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Completed

NCT Number: NCT01245374

Norditropin NordiFlex® Device Compared to 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.

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Key information

Conditions

Growth Hormone Disorder Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Chronic Disease Chronic Kidney Disease Chronic Renal Insufficiency Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Delivery Systems Disease Attributes Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Foetal Growth Problem Genetic Diseases, Inborn Genetic Disorder Gonadal Disorders Gonadal Dysgenesis Growth Hormone Deficiency in Children Heart Defects, Congenital Heart Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Small for Gestational Age Turner Syndrome Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norditropin NordiFlex®

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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).

  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).

  7. 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).

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2010
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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