Liquid Somatropin Formulation in Children With Growth Hormone Deficiency - Full Text View

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 in Children	Drug: somatropin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasia

Drug Information available for: Somatropin

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:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00567385 History of Changes
Other Study ID Numbers:	GHLIQUID-1515
Study First Received:	November 30, 2007
Last Updated:	March 24, 2012
Health Authority:	Turkey: Ministry of Health Drug and Pharmaceutical Department

Additional relevant MeSH terms:

Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases

Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012