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An open-source clinical intelligence platform. Explore clinical trials, gene networks, and molecular structures using public data sources.

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Safety and Efficacy of Long-term Somatropin Treatment in Children

N/ACompletedNCT01543867

Novo Nordisk A/S5,442 enrolled

Overview

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

Study Type

OBSERVATIONAL

Enrollment

5,442

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children Foetal Growth Problem Small for Gestational Age Genetic Disorder Turner Syndrome Growth Disorder Idiopathic Short Stature

NCT01543867 - Safety and Efficacy of Long-term Somatropin Treatment in Children | Crick | Crick

Interventions

somatropinDRUG

Prescribed at the discretion of the treating physician according to product labelling

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * In need of somatropin or current user

Locations (1)

Unnamed facility

Mainz, Germany

Outcomes

Primary Outcomes

Number of adverse events

Time frame: Up to 10 years

Secondary Outcomes

Number of patients continuing somatropin treatment

Time frame: Up to 10 years

Change in height

Time frame: Up to 10 years

Onset of puberty in children small for gestational age

Time frame: Up to 10 years

Co-morbidities in children small for gestational age

Time frame: Up to 10 years

Data from ClinicalTrials.gov

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