Special Survey for Long Term Application
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: June 26, 2012
Last verified: January 2012
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2012 | ||||
| Last Updated Date | June 26, 2012 | ||||
| Start Date ICMJE | May 1997 | ||||
| Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of adverse drug reactions (ADRs) [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01516229 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective [ Designated as safety issue: No ] | ||||
| 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 | Special Survey for Long Term Application | ||||
| Official Title ICMJE | Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application | ||||
| Brief Summary | This study is conducted in Japan. The aim of this study is to assess the incidence rate of adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients being treated with somatropin for achondroplasia without epiphyseal line closure |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: somatropin
Prescription of somatropin at the discretion of the physician |
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| Study Group/Cohort (s) | 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 | Completed | ||||
| Enrollment ICMJE | 395 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 15 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01516229 | ||||
| Other Study ID Numbers ICMJE | GH-1941 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Public Access to Clinical Trials, Novo Nordisk A/S | ||||
| Study Sponsor ICMJE | Novo Nordisk | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novo Nordisk | ||||
| Verification Date | January 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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