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Special Survey for Long Term Application

This study has been completed.
Sponsor:
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

January 19, 2012
February 23, 2017
May 1, 1997
March 31, 2007   (Final data collection date for primary outcome measure)
Incidence of adverse drug reactions (ADRs)
Same as current
Complete list of historical versions of study NCT01516229 on ClinicalTrials.gov Archive Site
Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective
Same as current
Not Provided
Not Provided
 
Special Survey for Long Term Application
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients being treated with somatropin for achondroplasia without epiphyseal line closure
  • Genetic Disorder
  • Achondroplasia
Drug: somatropin
Prescription of somatropin at the discretion of the physician
Somatropin
Intervention: Drug: somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
March 31, 2007
March 31, 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Achondroplasia without epiphyseal line closure
Sexes Eligible for Study: All
1 Year to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01516229
GH-1941
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP