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

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ClinicalTrials.gov Identifier: NCT00184730
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somatropin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA.
Study Start Date : November 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) [ Time Frame: at the end of treatment ]
  2. 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 :
  1. Adverse events
  2. FPG, insulin, and HbA1C
  3. Clinical laboratory tests

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184730


Locations
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Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184730    
Other Study ID Numbers: GHLIQUID-1650
JapicCTI-050134 ( Registry Identifier: japic )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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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