Safety and Efficacy of Long-term Somatropin Treatment in Adults (NordiWIN)
This study is enrolling participants by invitation only.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01543880
First received: February 28, 2012
Last updated: June 26, 2012
Last verified: June 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 28, 2012 | ||||
| Last Updated Date | June 26, 2012 | ||||
| Start Date ICMJE | July 2003 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of adverse events [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01543880 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of Long-term Somatropin Treatment in Adults | ||||
| Official Title ICMJE | Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults | ||||
| Brief Summary | This study is conducted in Europe. The aim of this study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Adults in need of somatropin or current users |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: somatropin
Prescribed at the discretion of the treating physician according to product labelling |
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| Study Group/Cohort (s) | Users of somatropin
Intervention: Drug: somatropin |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 427 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01543880 | ||||
| Other Study ID Numbers ICMJE | GH-1931 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Novo Nordisk | ||||
| Study Sponsor ICMJE | Novo Nordisk | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novo Nordisk | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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