Long-Term Trial on Growth Hormone Deficiency in Adults (GHDA) - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184730

Purpose

This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.

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

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) [ Time Frame: At the end of treatment ]
GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio) [ Time Frame: At the end of treatment ]

Secondary Outcome Measures:

Adverse events
FPG, insulin, and HbA1C
Clinical laboratory tests

Estimated Enrollment:	115
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	19 Years to 67 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who completed GHLiquid-1519.
If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded.
Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.

Exclusion Criteria:

Subject with a history of acromegaly.
Subject with diabetes mellitus.
Subject suffering from malignancy.
Several medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184730

Locations

Japan

Kobe city, Japan

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Yoshihisa Ogawa

Novo Nordisk Pharma Ltd.

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	GHLIQUID-1650, JAPIC: JapicCTI-050134
Study First Received:	September 13, 2005
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00184730
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases
Central Nervous System Diseases
Dwarfism, Pituitary

Brain Diseases
Bone Diseases
Growth hormone deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009