Special Survey for Long Term Application

Completed

• Conditions: Achondroplasia; Genetic Disorder
• Interventions: Drug: somatropin

• Registration Number: NCT01516229
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 1997-05-01
• Primary Completion: 2007-03-31
• Study Completion: 2007-03-31
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-24
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

• Achondroplasia without epiphyseal line closure

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Somatropin	somatropin	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions (ADRs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan