Special Survey for Long Term Application

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.

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Key information

Conditions

Genetic Disorder Achondroplasia Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Achondroplasia without epiphyseal line closure

Treatment and study plan

Somatropin

Drug

Prescription of somatropin at the discretion of the physician

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 1997
Primary completion: 2007
Study completion: 2007
First posted: Jan 24, 2012
Registry last updated: Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed