Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone

June 23, 2014 updated by: Novo Nordisk A/S

Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life

This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

77

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

  • France
      • Paris La défense cedex, France, 92932

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

No older than 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Growth hormone treatment naïve children for whom a prescription of Norditropin NordiFlex® is initiated according to the SPC (Summary of Product Characteristics)

Description

Inclusion Criteria:

  • Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
  • Subjects who receive Norditropin NordiFlex® according to the SPC

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Child and/or parent unable to give consent or fill out the questionnaires
  • The receipt of any investigational medicinal product within 3 months prior to this study
  • Suffer from a life-threatening disease

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
Norditropin NordiFlex® users
Drug: Norditropin NordiFlex®
Daily administration by subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Usability of growth hormone injection device assessed by a quantitative scale
Time Frame: after 3 months of growth hormone treatment
after 3 months of growth hormone treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: from 0 - 3 months of growth hormone treatment
from 0 - 3 months of growth hormone treatment
Number of technical complaints
Time Frame: from 0 to 3 months of growth hormone treatment
from 0 to 3 months of growth hormone treatment

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

April 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (ESTIMATE)

April 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-3870
  • U1111-1119-8619 (OTHER: WHO)

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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