Safety and Efficacy of Long-term Somatropin Treatment in Children

NCT01543867 | Completed

• 1 other identifier: GH-1930
• Study Type: observational
• Target: 5,442
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Up to 10 years

Secondary Outcomes (4)

• Number of patients continuing somatropin treatment

  Up to 10 years

• Change in height

  Up to 10 years

• Onset of puberty in children small for gestational age

  Up to 10 years

• Co-morbidities in children small for gestational age

  Up to 10 years

Study Arms (1)

Users of somatropin

Drug: somatropin

Interventions

somatropin DRUG

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

Users of somatropin

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children treated with somatropin

You may qualify if:

• In need of somatropin or current user

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Mainz, 55127, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Genetic Diseases, Inborn; Turner Syndrome; Growth Disorders

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 5, 2012
• Study Start: January 1, 2001
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

DE (1)