Trial | NCT02693522  Report issue

Title

Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    52
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency
Study Started
Oct 31
2003
Primary Completion
Dec 31
2004
Study Completion
Dec 31
2004
Last Update
Feb 29
2016
Estimate

Drug somatropin

Subcutaneous injection

Drug Eutropin

Subcutaneous injection

somatropin Experimental

Subcutaneous injection

Eutropin Active Comparator

Subcutaneous injection

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
No Results Posted