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Treatment of Adults With Growth Hormone Deficiency

Primary Purpose

Pituitary Disorders, Adult Growth Hormone Deficiency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
growth hormone
Sponsored by
LG Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Disorders focused on measuring Growth hormone deficiency

Eligibility Criteria

23 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female of at least 23 years and not more than 70 years of age GHD of either adult onset(AO)or Childhood onset(CO), either idiopathic or secondary to pituitary disease Confirmed diagnosis of GHD defined IGF-1 SDS ≤ -1 at screening No exposure to rhGH within the last 6 months Patients with adequate adrenal function, which is confirmed by ACTH stimulation test at screening; or Patients with known secondary hypoadrenalism on adequate glucocorticoid replacement therapy If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 3 months before study entry Women of child-bearing potential to be using a reliable method of contraception at the screening and be willing to use it throughout the study A negative serum pregnancy test is required at screening for females of child-bearing potential. Exclusion Criteria: History of malignancy other than cranial tumor or leukemia causing GHD or fully treated basal cell carcinoma Evidence of active malignancy Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months, or patients without MRI or CT data to confirm the tumor stability within the last 12 months Significant hepatic dysfunction Chronic renal impairment Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease Prader-Willi syndrome Acute severe illness in the last 6 months Benign intracranial hypertension Active Cushing's syndrome within the last 12 months Uncontrolled hypertension Patients with overt diabetes mellitus or evidence of persistent impaired glucose tolerance Severe psychiatric disease or patients who cannot understand the objective and methods of the study or patients with current alcohol abuse Pregnancy or lactation Known hypersensitivity to any ingredient of the study drug Inability to undergo scanning by dual-energy X ray absorptiometry (DXA) due to a body weight more than 130 kg or in situ internal or external devices known to interfere with DXA scanning Weight reducing drugs or appetite suppressants Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry Methylphenidate within 2 months before study entry Systemic corticosteroids other than in replacement doses within the 3 months before study entry. History of non-compliance with medications, un-cooperativeness or drug abuse Patients participating in another study parallel to, or within 6 months prior to study entry, or previous participation in this study Patients who are not able to comply with the study protocol for any reason.

Sites / Locations

  • Oregon Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LB03002

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in Fat Mass at the end of 26-week treatment from baseline

Secondary Outcome Measures

Changes in the following parameters at the end of 26-week treatment from baseline; other body composition parameters, QoL Score, Serum IGF-I, IGFBP-3 levels & SDS, Lipid profile, waist-to-hip ratio

Full Information

First Posted
February 20, 2006
Last Updated
October 4, 2012
Sponsor
LG Life Sciences
Collaborators
BioPartners GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00294619
Brief Title
Treatment of Adults With Growth Hormone Deficiency
Official Title
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
Collaborators
BioPartners GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate efficacy and safety profile of a new weekly administered growth hormone preparation compared with placebo in adults with growth hormone deficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Disorders, Adult Growth Hormone Deficiency
Keywords
Growth hormone deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LB03002
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
growth hormone
Intervention Description
subcutaneous injection, once-weekly
Primary Outcome Measure Information:
Title
Changes in Fat Mass at the end of 26-week treatment from baseline
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Changes in the following parameters at the end of 26-week treatment from baseline; other body composition parameters, QoL Score, Serum IGF-I, IGFBP-3 levels & SDS, Lipid profile, waist-to-hip ratio
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female of at least 23 years and not more than 70 years of age GHD of either adult onset(AO)or Childhood onset(CO), either idiopathic or secondary to pituitary disease Confirmed diagnosis of GHD defined IGF-1 SDS ≤ -1 at screening No exposure to rhGH within the last 6 months Patients with adequate adrenal function, which is confirmed by ACTH stimulation test at screening; or Patients with known secondary hypoadrenalism on adequate glucocorticoid replacement therapy If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 3 months before study entry Women of child-bearing potential to be using a reliable method of contraception at the screening and be willing to use it throughout the study A negative serum pregnancy test is required at screening for females of child-bearing potential. Exclusion Criteria: History of malignancy other than cranial tumor or leukemia causing GHD or fully treated basal cell carcinoma Evidence of active malignancy Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months, or patients without MRI or CT data to confirm the tumor stability within the last 12 months Significant hepatic dysfunction Chronic renal impairment Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease Prader-Willi syndrome Acute severe illness in the last 6 months Benign intracranial hypertension Active Cushing's syndrome within the last 12 months Uncontrolled hypertension Patients with overt diabetes mellitus or evidence of persistent impaired glucose tolerance Severe psychiatric disease or patients who cannot understand the objective and methods of the study or patients with current alcohol abuse Pregnancy or lactation Known hypersensitivity to any ingredient of the study drug Inability to undergo scanning by dual-energy X ray absorptiometry (DXA) due to a body weight more than 130 kg or in situ internal or external devices known to interfere with DXA scanning Weight reducing drugs or appetite suppressants Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry Methylphenidate within 2 months before study entry Systemic corticosteroids other than in replacement doses within the 3 months before study entry. History of non-compliance with medications, un-cooperativeness or drug abuse Patients participating in another study parallel to, or within 6 months prior to study entry, or previous participation in this study Patients who are not able to comply with the study protocol for any reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HJ Ji, PhD
Organizational Affiliation
LG Life Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Adults With Growth Hormone Deficiency

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