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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT01245374 (opens ClinicalTrials.gov in a new tab)Other idGH-3826Other idU1111-1117-1194Other id2009-017387-16Other id2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
103 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
Nov 2010
Primary completion
Apr 2011
Completion
Apr 2011
First posted
22 Nov 2010 (estimated)
Last update posted
27 Feb 2017
Conditions
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

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 4

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

    NCT01245374

    Nov 2010 to Apr 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Norditropin NordiFlex®Device

Arms1

  • 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)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used

    Time frame · Week 6

    Registry description

    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

    Registry description

    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(15)

  1. Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness

    Time frame · Week 0

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 6

The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used

GroupValue (units on a scale)Spread
Norditropin NordiFlex®6.892.52
Primary outcomeMean· Week 6

The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used

GroupValue (units on a scale)Spread
Norditropin NordiFlex®6.982.46
Secondary and other outcome results(6)
Secondary outcomeNumber· Week 0

Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness

GroupValue (percentage of participants)
Norditropin NordiFlex®55.3
Secondary outcomeNumber· Week 0

Percentage of Participants Evaluating Simplicity of Use: Dose Modification

GroupValue (percentage of participants)
Norditropin NordiFlex®26.0
Secondary outcomeNumber· Week 0

Percentage of Participants Evaluating Simplicity of Use: Injection Easiness

GroupValue (percentage of participants)
Norditropin NordiFlex®44.7
Secondary outcomeNumber· Week 0

Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection

GroupValue (percentage of participants)
Norditropin NordiFlex®86.4
Secondary outcomeNumber· Week 6

Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness

GroupValue (percentage of participants)
Norditropin NordiFlex®66.7
Secondary outcomeNumber· Week 6

Percentage of Participants Evaluating Simplicity of Use: Dose Modification

GroupValue (percentage of participants)
Norditropin NordiFlex®84.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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)–0 / 1030 / 103

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultTauber M, Jaquet D, Jesuran-Perelroizen M, Petrus M, Bertrand AM, Coutant R; NordiFlex(R) French Study Group. User assessment of Norditropin NordiFlex((R)), 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. PMID 23737664

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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