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Completed

NCT Number: NCT01543867

Safety and Efficacy of Long-term Somatropin Treatment in Children

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.

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Key information

Conditions

Growth Hormone Disorder Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Foetal Growth Problem Genetic Diseases, Inborn Genetic Disorder Gonadal Disorders Gonadal Dysgenesis Growth Disorder Growth Disorders Growth Hormone Deficiency in Children Heart Defects, Congenital Heart Diseases Idiopathic Short Stature Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Small for Gestational Age Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • In need of somatropin or current user

Treatment and study plan

Somatropin

Drug

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

Primary outcomes

  1. Number of adverse events

    Time frame: Up to 10 years

Secondary outcomes

  1. Number of patients continuing somatropin treatment

    Time frame: Up to 10 years

  2. Change in height

    Time frame: Up to 10 years

  3. Onset of puberty in children small for gestational age

    Time frame: Up to 10 years

  4. Co-morbidities in children small for gestational age

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)

Acronym: GrowthWIN II

Important dates

Study start
2001
Primary completion
2011
Study completion
2011
First posted
Mar 5, 2012
Registry last updated
Mar 30, 2015

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.

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