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 hGH in Long Term (More Than 48 Weeks) in GHDA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184730
• Other study ID #: GHLIQUID-1650
• Secondary ID: JapicCTI-050134
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 16, 2016
• Start date: November 2004
• Est. completion date: September 2006

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 67 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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	Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)		at the end of treatment	No
Primary	GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio)		at the end of treatment	No
Secondary	Adverse events			No
Secondary	FPG, insulin, and HbA1C			No
Secondary	Clinical laboratory tests			No

External Links

•   Clinical Trials at Novo Nordisk