Back to resultsGrowth 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 with diagnosed GHD
- If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have 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) from baseline
Secondary Outcome Measures
Change in total body fat, total LBM, etc. from baseline to 24 weeks
Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
Adverse events
Clinical laboratory tests
FPG, insulin, and HbA1c
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519558
Brief Title
Growth Hormone Deficiency in Adults (GHDA)
Official Title
Investigation of the Efficacy and Safety of NN-220 for 24 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
May 31, 2003 (Actual)
Primary Completion Date
January 24, 2005 (Actual)
Study Completion Date
January 24, 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. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Percent change in truncal fat (kg) from baseline
Time Frame
at 24 weeks (end of treatment)
Secondary Outcome Measure Information:
Title
Change in total body fat, total LBM, etc. from baseline to 24 weeks
Title
Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
Title
IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
Title
Adverse events
Title
Clinical laboratory tests
Title
FPG, insulin, and HbA1c
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 with diagnosed GHD
If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have 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
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Growth Hormone Deficiency in Adults (GHDA)
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