Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

This study has been completed.

First Received: November 30, 2007 Last Updated: June 8, 2009 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00567385

Purpose

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

Condition	Intervention	Phase
Growth Hormone Deficiency (GHD)	Drug: somatropin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Evaluating Acceptance of the New Liquid Growth Hormone Formulation, Norditropin® SimpleXx®, in Children With Growth Hormone Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Assessment of acceptance [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Designated as safety issue: No ]
Adverse Events (AE) [ Designated as safety issue: No ]
Compliance [ Designated as safety issue: No ]

Enrollment:	176
Study Start Date:	March 2003
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Growth failure due to growth hormone insufficiency (GHD)
Turner syndrome: established diagnosis according to sex chromosome analysis, or
Growth retardation in children with chronic renal disorders

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567385

Locations

Turkey

Altunizade-Istanbul, Turkey, 34662

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Asude Ademogullari, BSc

Novo Nordisk Saglik Urunleri Tic. Ltd. St.

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	GHLIQUID-1515
Study First Received:	November 30, 2007
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00567385 History of Changes
Health Authority:	Turkey: Ministry of Health Drug and Pharmaceutical Department

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases

Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on February 08, 2010