- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516229
Special Survey for Long Term Application
February 23, 2017 updated by: Novo Nordisk A/S
Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
395
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
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Tokyo, Japan, 103
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients being treated with somatropin for achondroplasia without epiphyseal line closure
Description
Inclusion Criteria:
- Achondroplasia without epiphyseal line closure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Somatropin
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Prescription of somatropin at the discretion of the physician
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of adverse drug reactions (ADRs)
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Secondary Outcome Measures
Outcome Measure |
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Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 1997
Primary Completion (Actual)
March 31, 2007
Study Completion (Actual)
March 31, 2007
Study Registration Dates
First Submitted
January 19, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 24, 2012
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 23, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH-1941
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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