Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
NCT ID: NCT01245374
Last Updated: 2017-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2010-11-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nordiflex Norditropin®
Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
Norditropin NordiFlex®
Daily administration by a subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice
Interventions
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Norditropin NordiFlex®
Daily administration by a subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice
Eligibility Criteria
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Inclusion Criteria
* Treated with growth hormone for at least one year
Exclusion Criteria
* Known or suspected hypersensitivity to somatropin or related products
* The receipt of any investigational medicinal product within 3 months prior to study start
* Life threatening disease, for example cancer
* Pregnancy or the intention of becoming pregnant
6 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Paris La Défense Cedex, , France
Countries
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References
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Tauber M, Jaquet D, Jesuran-Perelroizen M, Petrus M, Bertrand AM, Coutant R; NordiFlex(R) French Study Group. User assessment of Norditropin NordiFlex((R)), a new prefilled growth hormone pen: a Phase IV multicenter prospective study. Patient Prefer Adherence. 2013 May 24;7:455-62. doi: 10.2147/PPA.S43460. Print 2013.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1117-1194
Identifier Type: OTHER
Identifier Source: secondary_id
2009-017387-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GH-3826
Identifier Type: -
Identifier Source: org_study_id
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