Special Survey for Long Term Application

Achondroplasia Clinical Trial

Official title:

Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516229
• Other study ID #: GH-1941
• Status: Completed
• Phase: N/A
• First received: January 19, 2012
• Last updated: February 23, 2017
• Start date: May 1, 1997
• Est. completion date: March 31, 2007

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: March 31, 2007
• Est. primary completion date: March 31, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• Achondroplasia without epiphyseal line closure

Related Conditions & MeSH terms

• Achondroplasia
• Genetic Disorder

Intervention

Drug:
• somatropin
Prescription of somatropin at the discretion of the physician

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions (ADRs)
Secondary	Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective

External Links

•   Clinical Trials at Novo Nordisk