Back to resultsLong-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Primary Purpose
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Disorder
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio)
Secondary Outcome Measures
Adverse events
FPG, insulin, and HbA1C
Clinical laboratory tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00184730
Brief Title
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Official Title
Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Adult Growth Hormone Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
Time Frame
at the end of treatment
Title
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 Measure Information:
Title
Adverse events
Title
FPG, insulin, and HbA1C
Title
Clinical laboratory tests
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
1000005
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
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