Evaluation of Efficacy and Safety of Recombinant Somatroi... | NCT02693522

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

NCT02693522

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Feb 29, 2016Estimated

Enrollment

52Actual

Phase

Phase 3

Conditions

Growth Hormone Deficiency

Interventions

somatropin
Eutropin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Jan 19, 2016

First Submission Date that Met QC Criteria

Feb 23, 2016

First Posted Date

Feb 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2016

Last Update Posted Date

Feb 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
somatropin	Experimental	Subcutaneous injection	Drug: somatropin
Eutropin	Active Comparator	Subcutaneous injection	Drug: Eutropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug	Subcutaneous injection	somatropin
Eutropin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of fat mass (FM) reduction	statistically difference for change from baseline (kg)	baseline and 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Degree of variation in Lean Body Mass	statistically difference for change from baseline (kg)	baseline and 24 weeks
Degree of variation in Waist to Hip Ratio	statistically difference for change from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019382	Human Growth Hormone

Ancestor Terms

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided