Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Completed

• Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Delivery Systems
• Interventions: Device: NordiFlex PenMate™

• Registration Number: NCT01500486
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-28
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PenMate device	NordiFlex PenMate™	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Malmö, Sweden