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Special Survey for Long Term Application
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: February 23, 2017
Last verified: February 2017
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | January 19, 2012 | |||
| Last Updated Date | February 23, 2017 | |||
| Actual Start Date ICMJE | May 1, 1997 | |||
| Primary Completion Date | March 31, 2007 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Incidence of adverse drug reactions (ADRs) | |||
| 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 | |||
| 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. | |||
| 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 | |||
| Condition ICMJE |
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| Intervention ICMJE | Drug: somatropin
Prescription of somatropin at the discretion of the physician |
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| Study Groups/Cohorts | 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 31, 2007 | |||
| Primary Completion Date | March 31, 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Sex/Gender |
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| Ages | 1 Year to 15 Years (Child) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01516229 | |||
| Other Study ID Numbers ICMJE | GH-1941 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Novo Nordisk A/S | |||
| Study Sponsor ICMJE | Novo Nordisk A/S | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Novo Nordisk A/S | |||
| Verification Date | February 2017 | |||
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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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