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

Phase 3

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: somatropin; Drug: Eutropin

• Registration Number: NCT02693522
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2016-01-19
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-26
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
somatropin	somatropin	Subcutaneous injection
Eutropin	Eutropin	Subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Degree of fat mass (FM) reduction	baseline and 24 weeks	statistically difference for change from baseline (kg)

Secondary Outcome Measures

Name	Time	Method
Degree of variation in Lean Body Mass	baseline and 24 weeks	statistically difference for change from baseline (kg)
Degree of variation in Waist to Hip Ratio	baseline and 24 weeks	statistically difference for change from baseline
Degree of variation in IGF-1	baseline and 24 weeks	statistically difference for change from baseline (ng/ml)

Trial Locations

Locations (1)

Kyunghee University Hospital; 🇰🇷 Seoul, Korea, Republic of