Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Adult Growth Hormone Deficiency Clinical Trial

Official title:

Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184743
• Other study ID #: GHLIQUID-1519
• Secondary ID: JapicCTI-050133
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: February 27, 2017
• Start date: December 6, 2003
• Est. completion date: December 28, 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 28, 2005
• Est. primary completion date: December 28, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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 the baseline to the end of treatment
Secondary	Adverse events
Secondary	Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment
Secondary	Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
Secondary	FPG, insulin, and HbA1C
Secondary	IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
Secondary	Clinical laboratory tests

External Links

•   Clinical Trials at Novo Nordisk