NCT01500486

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2011

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

December 22, 2011

Last Update Submit

November 16, 2016

Conditions

Growth Hormone DisorderGrowth Hormone Deficiency in ChildrenDelivery Systems

Outcome Measures

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

    Week 12

Secondary Outcomes (4)

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

    Week 0

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

    Week 12

  • Compliance to treatment as assessed by patient/parent diary

    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

    Week 12

Study Arms (1)

PenMate device

Device: NordiFlex PenMate™

Interventions

NordiFlex PenMate™DEVICE

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.

PenMate device

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Location

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Location

Novo Nordisk Investigational Site

Malmo, 202 15, Sweden

Location

Novo Nordisk Investigational Site

Malmo, SE-202 15, Sweden

Location

Related Links

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 28, 2011

Study Start

January 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

SE(2)NL(1)DE(1)