Special Survey for Long Term Application
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: June 26, 2012
Last verified: January 2012
History of Changes
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  Purpose
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	Intervention
Genetic Disorder
Achondroplasia
Drug: somatropin

Study Type:	 Observational
Study Design:	Observational Model: Cohort
Time Perspective: Prospective
Official Title:	Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application

Resource links provided by NLM:

Genetics Home Reference related topics: achondroplasia metatropic dysplasia mucopolysaccharidosis type IV pseudoachondroplasia
Drug Information available for: Somatropin
U.S. FDA Resources 

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
Incidence of adverse drug reactions (ADRs) [ Designated as safety issue: No ]

Secondary Outcome Measures:
Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective [ Designated as safety issue: No ]

Enrollment:	395
Study Start Date:	May 1997
Study Completion Date:	March 2007
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts	 Assigned Interventions
Somatropin	 Drug: somatropin
Prescription of somatropin at the discretion of the physician

   Eligibility

Ages Eligible for Study:  	1 Year to 15 Years
Genders Eligible for Study:  	Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516229

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director:	Masayuki Senda	Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk   This link exits the ClinicalTrials.gov site

No publications provided 

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01516229     History of Changes
Other Study ID Numbers:	GH-1941
Study First Received:	January 19, 2012
Last Updated:	June 26, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Achondroplasia
Genetic Diseases, Inborn
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias

ClinicalTrials.gov processed this record on November 22, 2013