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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
NCT00184730 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
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Scientific title:
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Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA. |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00184730 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
67 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adult Growth Hormone Deficiency
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Growth Hormone Disorder
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Intervention(s)
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Drug: somatropin
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Primary Outcome(s)
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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]
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Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
[Time Frame: at the end of treatment]
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Secondary Outcome(s)
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FPG, insulin, and HbA1C
[Time Frame: No]
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Adverse events
[Time Frame: No]
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Clinical laboratory tests
[Time Frame: No]
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Secondary ID(s)
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GHLIQUID-1650
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JapicCTI-050134
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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