Special Survey for Long Term Application

Tracking Information
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; (submitted: January 19, 2012)	Incidence of adverse drug reactions (ADRs)
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01516229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: January 19, 2012)	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 Outcome Measures	Not Provided
Original Other 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
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	Genetic Disorder; Achondroplasia
Intervention	Drug: somatropin; Prescription of somatropin at the discretion of the physician
Study Groups/Cohorts	Somatropin; Intervention: Drug: somatropin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: January 19, 2012)	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: Achondroplasia without epiphyseal line closure
Sex/Gender	Sexes Eligible for Study: All
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
Responsible Party	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account	Novo Nordisk A/S
Verification Date	February 2017