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-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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Percent change in truncal fat (kg)
Secondary Outcome Measures
Adverse events
Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment
Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
FPG, insulin, and HbA1C
IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
Clinical laboratory tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00184743
Brief Title
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Official Title
Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 6, 2003 (Actual)
Primary Completion Date
December 28, 2005 (Actual)
Study Completion Date
December 28, 2005 (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. 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.
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
112 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Percent change in truncal fat (kg)
Time Frame
from the baseline to the end of treatment
Secondary Outcome Measure Information:
Title
Adverse events
Title
Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment
Title
Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
Title
FPG, insulin, and HbA1C
Title
IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
Title
Clinical laboratory tests
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Citations:
PubMed Identifier
18395480
Citation
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. doi: 10.1016/j.ghir.2008.02.002. Epub 2008 Apr 18.
Results Reference
derived
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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