Clinical Trial: Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency

Detailed Summary:
Sponsor: Daewoong Pharmaceutical Co. LTD.

Current Primary Outcome: Degree of fat mass (FM) reduction [ Time Frame: baseline and 24 weeks ]

statistically difference for change from baseline (kg)


Original Primary Outcome: Degree of fat mass (FM) reduction [ Time Frame: 24 weeks ]

statistically differene for change from baseline (kg)


Current Secondary Outcome:

  • Degree of variation in Lean Body Mass [ Time Frame: baseline and 24 weeks ]
    statistically difference for change from baseline (kg)
  • Degree of variation in Waist to Hip Ratio [ Time Frame: baseline and 24 weeks ]
    statistically difference for change from baseline
  • Degree of variation in IGF-1 [ Time Frame: baseline and 24 weeks ]
    statistically difference for change from baseline (ng/ml)


Original Secondary Outcome:

  • Degree of variation in Lean Body Mass [ Time Frame: 24 weeks ]
    statistically differene for change from baseline (kg)
  • Degree of variation in Waist to Hip Ratio [ Time Frame: 24 weeks ]
    statistically differene for change from baseline
  • Degree of variation in IGF-1 [ Time Frame: 24 weeks ]
    statistically differene for change from baseline (ng/ml)


Information By: Daewoong Pharmaceutical Co. LTD.

Dates:
Date Received: January 19, 2016
Date Started: October 2003
Date Completion:
Last Updated: February 26, 2016
Last Verified: February 2016