Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Growth Hormone Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500486
• Other study ID #: GH-3717
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: November 16, 2016
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Dutch Health Care InspectorateSweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delivery Systems
• Dwarfism, Pituitary
• Growth Hormone Deficiency in Children
• Growth Hormone Disorder

Intervention

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.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz
Netherlands	Novo Nordisk Investigational Site	Alphen a/d Rijn
Sweden	Novo Nordisk Investigational Site	Malmö
Sweden	Novo Nordisk Investigational Site	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires		Week 0	No
Secondary	Patient/parent overall acceptance of Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by questionnaire		Week 12	No
Secondary	Compliance to treatment as assessed by patient/parent diary		Week 12	No
Secondary	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	No

External Links

•   Clinical Trials at Novo Nordisk