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

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184743

Purpose

This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.

Condition	Intervention	Phase
Growth Hormone Deficiency, Adults (GHDA)	Drug: somatropin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Percent change in truncal fat (kg) [ Time Frame: from the baseline to the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Designated as safety issue: No ]
Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment [ Designated as safety issue: No ]
Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) [ Designated as safety issue: No ]
FPG, insulin, and HbA1C [ Designated as safety issue: No ]
IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio [ Designated as safety issue: No ]
Clinical laboratory tests [ Designated as safety issue: No ]

Enrollment:	112
Study Start Date:	December 2003
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who completed GHLiquid-1518.
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: NCT00184743

Locations

Japan

Kobe city, Japan

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Yoshihisa Ogawa

Novo Nordisk Pharma Ltd.

More Information

Additional Information:

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chihara K, Kato Y, Shimatsu A, Tanaka T, Kohno H. Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency. Growth Horm IGF Res. 2008 Oct;18(5):394-403. Epub 2008 Apr 18.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00184743 History of Changes
Other Study ID Numbers:	GHLIQUID-1519, JAPIC: JapicCTI-050133
Study First Received:	September 13, 2005
Last Updated:	July 7, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 February 09, 2012