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CompletedNCT01500486Updated Nov 17, 2016

Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

An observational study in Growth Hormone Disorder, Growth Hormone Deficiency in Children and Delivery Systems, sponsored by Novo Nordisk A/S. Completed at 4 sites in 3 countries. Per ClinicalTrials.gov, last updated 2016-11-17.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
84
Sex
All
01

Study summary

This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device - is also evaluated.

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Conditions studied

  • Growth Hormone Disorder
  • Growth Hormone Deficiency in Children
  • Delivery Systems
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In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects from secondary care physicians who prescribe growth hormone will be included in the study. Children who are available for Norditropin® treatment in accordance with the labelling will be included in the study: Newly-diagnosed subjects who have never received growth hormone therapy before and subjects in whom physician identifies a need for switch to another growth hormone preparation

Inclusion criteria

  • After the physician decision has been made to use Norditropin Nordiflex® growth hormone therapy in accordance with the locally approved labelling, any subject is eligible for the study, including newly diagnosed subjects who have never received growth hormone therapy before and subjects who were treated with the other growth hormone products (with exclusion of patients who received previously Norditropin Nordiflex®) and need to be switched to a new product. The selection of the subjects will be at the discretion of the individual physician

Exclusion criteria

Exclusion Criteria:

  • Contraindications to Norditropin® growth hormone therapy
  • Subjects who have received Norditropin NordiFlex® prior to this study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
84 participants (actual)
Patient registry
No

Groups and cohorts

  • PenMate device

    Device: NordiFlex PenMate™

Interventions

  • DeviceNordiFlex PenMate™

    Subjects whom will be offered growth hormone (Norditropin NordiFlex®) on prescription as part of normal clinical practice will be asked to evaluate the NordiFlex PenMate™ device.

06

What researchers measure

Primary outcomes

  1. The proportion of subjects that find growth hormone injection using Norditropin Nordiflex® with NordiFlex PenMate™ very easy or easy as assessed by patient/parent questionnaire

    Time frame: Week 12

Secondary outcomes

  1. Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires

    Time frame: Week 0

  2. Patient/parent overall acceptance of Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by questionnaire

    Time frame: Week 12

  3. Compliance to treatment as assessed by patient/parent diary

    Time frame: Week 12

  4. Evaluation of tolerability, when using Norditropin Nordiflex® with NordiFlex PenMate™, by collecting Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) and clinical technical complaints

    Time frame: Week 12

07

Study locations

4 sites
  • Novo Nordisk Investigational Site
    Mainz, 55127, Germany
  • Novo Nordisk Investigational Site
    Alphen a/d Rijn, Netherlands
  • Novo Nordisk Investigational Site
    Malmö, 202 15, Sweden
  • Novo Nordisk Investigational Site
    Malmö, SE-202 15, Sweden
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01500486
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 28, 2011
Start date
Jan 2007
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Nov 17, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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