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Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00184730
First received: September 13, 2005
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  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 Disorder
Adult Growth Hormone Deficiency
 Drug: somatropin
 Phase 3

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 hGH in Long Term (More Than 48 Weeks) in GHDA.

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]
  • FPG, insulin, and HbA1C [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: November 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  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

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: NCT00184730     History of Changes
Other Study ID Numbers: GHLIQUID-1650, JapicCTI-050134
Study First Received: September 13, 2005
Last Updated: June 28, 2012
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

ClinicalTrials.gov processed this record on May 23, 2013