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

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: NCT02693522
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE February 26, 2016
Last Update Posted Date February 29, 2016
Study Start Date  ICMJE October 2003
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
Degree of fat mass (FM) reduction [ Time Frame: baseline and 24 weeks ]
statistically difference for change from baseline (kg)
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
Degree of fat mass (FM) reduction [ Time Frame: 24 weeks ]
statistically differene for change from baseline (kg)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
  • 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 Measures  ICMJE
 (submitted: February 23, 2016)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • Drug: somatropin
    Subcutaneous injection
  • Drug: Eutropin
    Subcutaneous injection
Study Arms  ICMJE
  • Experimental: somatropin
    Subcutaneous injection
    Intervention: Drug: somatropin
  • Active Comparator: Eutropin
    Subcutaneous injection
    Intervention: Drug: Eutropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2016)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18 and up
  • Patients with maximum serum growth hormone concentration of less than 5 ng/ml
  • Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study
  • Persons who have agreed in writing to participate in this study

Exclusion Criteria:

  • Persons who are currently under treatment after being diagnosed with a malignant tumor
  • Hepatosis
  • Renal function disorder
  • Intra-cranial hypertension
  • Proliferative diabetic retinopathy
  • Persons who carry acromegaly activity
  • Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin)
  • Mental patients and/or drug addicts and alcoholics
  • Patients who had participated in the other drug study within the last 30 days prior to participating in this study
  • Patients considered unfit for this study by the attending physician
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02693522
Other Study ID Numbers  ICMJE DW_CTP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daewoong Pharmaceutical Co. LTD.
Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP