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

Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693522
• Other study ID #: DW_CTP
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2016
• Last updated: February 26, 2016
• Start date: October 2003
• Est. completion date: December 2004

Study information

• Verified date: February 2016
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Drug:
• somatropin
Subcutaneous injection
• Eutropin
Subcutaneous injection

Locations

Country	Name	City	State
Korea, Republic of	Kyunghee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of fat mass (FM) reduction	statistically difference for change from baseline (kg)	baseline and 24 weeks	Yes
Secondary	Degree of variation in Lean Body Mass	statistically difference for change from baseline (kg)	baseline and 24 weeks	Yes
Secondary	Degree of variation in Waist to Hip Ratio	statistically difference for change from baseline	baseline and 24 weeks	Yes
Secondary	Degree of variation in IGF-1	statistically difference for change from baseline (ng/ml)	baseline and 24 weeks	Yes