Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.

Completed

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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 Genetic Diseases, Inborn Genetic Disorder Gonadal Disorders Gonadal Dysgenesis Growth Hormone Deficiency in Children Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Afula, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Written Informed Consent by patient and/or guardian/parents
Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
Patients on growth hormone therapy for at least 6 weeks before entering the trial

Exclusion criteria

Pregnancy or breast feeding women
Suspected or known allergy to trial product
Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
Participating in any other trial involving other investigational products within the last 3 months

Treatment and study plan

Somatropin

Drug

Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)

Primary outcomes

Patient acceptance of the new liquid growth hormone formulation

Secondary outcomes

Number of Adverse Events (AE)
Number of Serious Adverse Events (SAE)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency

Important dates

Study start: 2000
Primary completion: 2002
Study completion: 2002
First posted: Mar 27, 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