Special Survey for Long Term Application
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ClinicalTrials.gov Identifier: NCT01516229 |
Recruitment Status :
Completed
First Posted : January 24, 2012
Last Update Posted : February 27, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
Tracking Information | ||||
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First Submitted Date | January 19, 2012 | |||
First Posted Date | January 24, 2012 | |||
Last Update Posted Date | February 27, 2017 | |||
Actual Study Start Date | May 1, 1997 | |||
Actual Primary Completion Date | March 31, 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Incidence of adverse drug reactions (ADRs) | |||
Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Special Survey for Long Term Application | |||
Official Title | 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 | Observational | |||
Study Design | 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 |
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Intervention | 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 | |||
* 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 | Completed | |||
Actual Enrollment |
395 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | March 31, 2007 | |||
Actual Primary Completion Date | March 31, 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 1 Year to 15 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01516229 | |||
Other Study ID Numbers | GH-1941 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Current Responsible Party | Novo Nordisk A/S | |||
Original Responsible Party | Public Access to Clinical Trials, Novo Nordisk A/S | |||
Current Study Sponsor | Novo Nordisk A/S | |||
Original Study Sponsor | Same as current | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Novo Nordisk A/S | |||
Verification Date | February 2017 |