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NCT01605331 Clinical Trial

Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

Growth Hormone Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01605331
Other study ID # LG-SHCL007
Secondary ID
Status Completed
Phase Phase 4
First received May 22, 2012
Last updated October 3, 2012
Start date December 2009
Est. completion date September 2010

Study information
Verified date October 2012
Source LG Life Sciences
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Men and women aged = 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• sustained-release recombinant human GH (SR-rhGH)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
LG Life Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Adverse event 12 weeks Yes
Secondary Efficacy QoL-AGHDA 12 weeks No
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