Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

November 16, 2016 updated by: Novo Nordisk A/S

Observational Study to Assess Ease of Use, Acceptability and Preference of Norditropin NordiFlex® With NordiFlex PenMate™ in Subjects on Prescribed Growth Hormone Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

84

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PenMate device
Device: NordiFlex 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires
Time Frame: Week 0
Week 0
Patient/parent overall acceptance of Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by questionnaire
Time Frame: Week 12
Week 12
Compliance to treatment as assessed by patient/parent diary
Time Frame: Week 12
Week 12
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
Week 12

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.

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

January 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (ESTIMATE)

December 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GH-3717

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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