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

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
somatropin
Eutropin
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyunghee University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

somatropin

Eutropin

Arm Description

Subcutaneous injection

Subcutaneous injection

Outcomes

Primary Outcome Measures

Degree of fat mass (FM) reduction
statistically difference for change from baseline (kg)

Secondary Outcome Measures

Degree of variation in Lean Body Mass
statistically difference for change from baseline (kg)
Degree of variation in Waist to Hip Ratio
statistically difference for change from baseline
Degree of variation in IGF-1
statistically difference for change from baseline (ng/ml)

Full Information

First Posted
January 19, 2016
Last Updated
February 26, 2016
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT02693522
Brief Title
Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
somatropin
Arm Type
Experimental
Arm Description
Subcutaneous injection
Arm Title
Eutropin
Arm Type
Active Comparator
Arm Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Eutropin
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Degree of fat mass (FM) reduction
Description
statistically difference for change from baseline (kg)
Time Frame
baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Degree of variation in Lean Body Mass
Description
statistically difference for change from baseline (kg)
Time Frame
baseline and 24 weeks
Title
Degree of variation in Waist to Hip Ratio
Description
statistically difference for change from baseline
Time Frame
baseline and 24 weeks
Title
Degree of variation in IGF-1
Description
statistically difference for change from baseline (ng/ml)
Time Frame
baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kyunghee University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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