To assess ease of use, acceptability and preference of Norditropin NordiFlex® in subjects on prescribed growth hormone therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017387-16-FR

Enrollment

200

Registered

2010-02-23

Start date

2010-08-31

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children aged 6 years or more receiving growth hormone therapy for the following approved indications (according to Norditropine SPC) -GHD -Turner Syndrome -small for gestational age -chronic renal insufficiency

Interventions

Trade Name: Norditropine NordiFleX Product Name: Norditropine NordiFleX Pharmaceutical Form: Solution for injection INN or Proposed INN: somatropin Concentration unit: mg/ml milligram(s)/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Only children whom Norditropin® treatment is indicated in accordance with labelling will be included in this study • Children receiving growth hormone therapy for at least one year • Age = 6 years written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Contraindications to Norditropin® growth hormone therapy as stated in the summary of product characteristics. • Patients who have previously been enrolled in this study. • The receipt of any investigational medicinal product within 3 months prior to this trial. • Suffer from a life threatening disease

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to investigate how easy/difficult patients/parents assess growth hormone injection using Norditropin NordiFlex® by quantifying the proportion of patients that find growth hormone injection using Norditropin NordiFlex® easy or very easy as assessed by patient/parent questionnaire at the end of study.;Secondary Objective: • Patient/parent overall acceptance/convenience of Norditropin NordiFlex® as assessed by questionnaire at the end of study. • Patients’/parents’ preference to use Norditropin NordiFlex® in comparison to the previous delivery systems. • Influence of NordiFlex PenMate® on overall acceptability/convenience • Compliance to treatment as assessed by patient/parent diary and drug accountability at the end of study • Ease of teaching how to use Norditropin NordiFlex® as assessed by nurse questionnaires at baseline visit. • Evaluation of tolerability, when using Norditropin NordiFlex® by collecting adverse events, serious adverse events, MESI and Clinical Technical Complaints. ;Primary end point(s): is to investigate how easy/difficult patients/parents assess growth hormone injection using Norditropin NordiFlex® by quantifying the proportion of patients that find growth hormone injection using Norditropin NordiFlex® easy or very easy as assessed by patient/parent questionnaire at the end of study.	—

Measure

Time frame

Main Objective: The primary objective of this study is to investigate how easy/difficult patients/parents assess growth hormone injection using Norditropin NordiFlex® by quantifying the proportion of patients that find growth hormone injection using Norditropin NordiFlex® easy or very easy as assessed by patient/parent questionnaire at the end of study.;Secondary Objective: • Patient/parent overall acceptance/convenience of Norditropin NordiFlex® as assessed by questionnaire at the end of study. • Patients’/parents’ preference to use Norditropin NordiFlex® in comparison to the previous delivery systems. • Influence of NordiFlex PenMate® on overall acceptability/convenience • Compliance to treatment as assessed by patient/parent diary and drug accountability at the end of study • Ease of teaching how to use Norditropin NordiFlex® as assessed by nurse questionnaires at baseline visit. • Evaluation of tolerability, when using Norditropin NordiFlex® by collecting adverse events, serious adverse events, MESI and Clinical Technical Complaints. ;Primary end point(s): is to investigate how easy/difficult patients/parents assess growth hormone injection using Norditropin NordiFlex® by quantifying the proportion of patients that find growth hormone injection using Norditropin NordiFlex® easy or very easy as assessed by patient/parent questionnaire at the end of study.

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026