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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Hormones

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