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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

Study Description
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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.

Condition or disease Intervention/treatment
Genetic Disorder Achondroplasia Drug: somatropin

Study Design
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Study Type : Observational
Actual Enrollment : 395 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application
Actual Study Start Date : May 1, 1997
Actual Primary Completion Date : March 31, 2007
Actual Study Completion Date : March 31, 2007

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Somatropin Drug: somatropin
Prescription of somatropin at the discretion of the physician


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse drug reactions (ADRs)

Secondary Outcome Measures :
  1. Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients being treated with somatropin for achondroplasia without epiphyseal line closure
Criteria

Inclusion Criteria:

  • Achondroplasia without epiphyseal line closure
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516229


Locations
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Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Novo Nordisk Investigational Site
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01516229    
Other Study ID Numbers: GH-1941
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Achondroplasia
Genetic Diseases, Inborn
Dwarfism
Bone Diseases, Developmental
 Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias