EUCTR2009-017387-16-FR
Active, not recruiting
Phase 1
To assess ease of use, acceptability and preference of Norditropin NordiFlex® in subjects on prescribed growth hormone therapy
ovo Nordisk Pharmaceutique S.A.S0 sites0 target enrollmentFebruary 23, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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
- Sponsor
- ovo Nordisk Pharmaceutique S.A.S
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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