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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.

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

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: somatropin Drug: Eutropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency
Study Start Date : October 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004


Arm Intervention/treatment
Experimental: somatropin
Subcutaneous injection
Drug: somatropin
Subcutaneous injection

Active Comparator: Eutropin
Subcutaneous injection
Drug: Eutropin
Subcutaneous injection




Primary Outcome Measures :
  1. Degree of fat mass (FM) reduction [ Time Frame: baseline and 24 weeks ]
    statistically difference for change from baseline (kg)


Secondary Outcome Measures :
  1. Degree of variation in Lean Body Mass [ Time Frame: baseline and 24 weeks ]
    statistically difference for change from baseline (kg)

  2. Degree of variation in Waist to Hip Ratio [ Time Frame: baseline and 24 weeks ]
    statistically difference for change from baseline

  3. Degree of variation in IGF-1 [ Time Frame: baseline and 24 weeks ]
    statistically difference for change from baseline (ng/ml)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693522


Locations
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Korea, Republic of
Kyunghee University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.

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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02693522     History of Changes
Other Study ID Numbers: DW_CTP
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Endocrine System Diseases
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs