Treatment of Adults With Growth Hormone Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00294619
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : October 5, 2012
BioPartners GmbH
Information provided by (Responsible Party):
LG Life Sciences

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.

Condition or disease Intervention/treatment Phase
Pituitary Disorders Adult Growth Hormone Deficiency Drug: growth hormone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: LB03002 Drug: growth hormone
subcutaneous injection, once-weekly
Placebo Comparator: Placebo Drug: growth hormone
subcutaneous injection, once-weekly

Primary Outcome Measures :
  1. Changes in Fat Mass at the end of 26-week treatment from baseline [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   23 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00294619

United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States
Sponsors and Collaborators
LG Life Sciences
BioPartners GmbH
Study Chair: HJ Ji, PhD LG Life Sciences

Responsible Party: LG Life Sciences Identifier: NCT00294619     History of Changes
Other Study ID Numbers: BPLG-005
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012

Keywords provided by LG Life Sciences:
Growth hormone deficiency

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Pituitary Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs