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

Phase 1

• 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

• Registration Number: EUCTR2009-017387-16-FR
• Lead Sponsor: ovo Nordisk Pharmaceutique S.A.S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-23
• Study Completion: 2011-04-18
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified