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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01605331
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: sustained-release recombinant human GH (SR-rhGH) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2009
Primary Completion Date : September 2010
Study Completion Date : September 2010


Arms and Interventions

Arm Intervention/treatment
Experimental: sustained-release recombinant human GH (SR-rhGH)
12-week subcutaneous administration, 2mg/week
Drug: sustained-release recombinant human GH (SR-rhGH)


Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: 12 weeks ]
    Adverse event


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 12 weeks ]
    QoL-AGHDA


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)
More Information

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01605331     History of Changes
Other Study ID Numbers: LG-SHCL007
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012

Keywords provided by LG Life Sciences:
Adults
GH deficiency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases