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

Daewoong Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Growth Hormone Deficiency

Treatments

Drug: somatropin

Drug: Eutropin

Study type

Interventional

Funder types

Industry

Identifiers

DW_CTP

Details and patient eligibility

About

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

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No 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