Special Survey for Long Term Application

Novo Nordisk A/S395 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

395

Conditions

Genetic Disorder Achondroplasia

Interventions

somatropinDRUG

Prescription of somatropin at the discretion of the physician

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Achondroplasia without epiphyseal line closure

Locations (2)

Novo Nordisk Investigational Site

Tokyo, Japan

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of adverse drug reactions (ADRs)

Secondary Outcomes

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

Data from ClinicalTrials.gov

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