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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01605331
First received: May 22, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Growth Hormone Deficiency
 Drug: sustained-release recombinant human GH (SR-rhGH)
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse event


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    QoL-AGHDA


Enrollment: 132
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sustained-release recombinant human GH (SR-rhGH)
12-week subcutaneous administration, 2mg/week
 Drug: sustained-release recombinant human GH (SR-rhGH)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01605331     History of Changes
Other Study ID Numbers: LG-SHCL007
Study First Received: May 22, 2012
Last Updated: October 3, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by LG Life Sciences:
Adults
GH deficiency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
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

ClinicalTrials.gov processed this record on May 19, 2013