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Special Survey for Long Term Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01516229
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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
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 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
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