Special Survey for Long Term Application

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01516229

Enrollment

395

Registered

2012-01-24

Start date

1997-05-01

Completion date

2007-03-31

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achondroplasia, Genetic Disorder

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.

Interventions

DRUGsomatropin

Prescription of somatropin at the discretion of the physician

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 15 Years

Healthy volunteers

Inclusion criteria

* Achondroplasia without epiphyseal line closure

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions (ADRs)	—

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026