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

February 26, 2016 updated by: Daewoong Pharmaceutical Co. LTD.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: somatropin
Subcutaneous injection
Drug: somatropin
Subcutaneous injection
Active Comparator: Eutropin
Subcutaneous injection
Drug: Eutropin
Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_CTP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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