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Special Survey for Long Term Application

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01516229

First Posted: January 24, 2012

Last Update Posted: February 27, 2017

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.

Information provided by (Responsible Party):

Novo Nordisk A/S

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

Drug Information available for: Somatropin

Genetic and Rare Diseases Information Center resources: Achondroplasia Mucopolysaccharidosis Type IV

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

Incidence of adverse drug reactions (ADRs)

Secondary Outcome Measures:

Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective


Enrollment:	395
Actual Study Start Date:	May 1, 1997
Study Completion Date:	March 31, 2007
Primary Completion Date:	March 31, 2007 (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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Novo Nordisk Investigational Site
Tokyo, Japan, 103

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

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


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01516229 History of Changes
Other Study ID Numbers:	GH-1941
First Submitted:	January 19, 2012
First Posted:	January 24, 2012
Last Update Posted:	February 27, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:


Achondroplasia Dwarfism Bone Diseases, Developmental Bone Diseases	Musculoskeletal Diseases Osteochondrodysplasias Genetic Diseases, Inborn

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