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Clinical Trials/EUCTR2009-017387-16-FR
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.

Registry
who.int
Start Date
February 23, 2010
End Date
April 18, 2011
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ovo Nordisk Pharmaceutique S.A.S

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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