Growth Hormone Deficiency in Adults (GHDA)

Adult Growth Hormone Deficiency Clinical Trial

Official title:

Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519558
• Other study ID #: GHLIQUID-1518
• Secondary ID: JapicCTI-R070007
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2007
• Last updated: February 27, 2017
• Start date: May 31, 2003
• Est. completion date: January 24, 2005

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 24, 2005
• Est. primary completion date: January 24, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

Intervention

Drug:
• somatropin

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in truncal fat (kg) from baseline		at 24 weeks (end of treatment)
Secondary	Change in total body fat, total LBM, etc. from baseline to 24 weeks
Secondary	Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
Secondary	IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
Secondary	Adverse events
Secondary	Clinical laboratory tests
Secondary	FPG, insulin, and HbA1c

External Links

•   Clinical Trials at Novo Nordisk