Treatment of Adults With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Collaborator:
BioPartners GmbH
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT00294619
First received: February 20, 2006
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Pituitary Disorders
Adult Growth Hormone Deficiency
Drug: growth hormone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Changes in Fat Mass at the end of 26-week treatment from baseline [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 147
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LB03002 Drug: growth hormone
subcutaneous injection, once-weekly
Placebo Comparator: Placebo Drug: growth hormone
subcutaneous injection, once-weekly

  Eligibility

Ages Eligible for Study:   23 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294619

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

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT00294619     History of Changes
Other Study ID Numbers: BPLG-005
Study First Received: February 20, 2006
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by LG Life Sciences:
Growth hormone deficiency

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

ClinicalTrials.gov processed this record on July 28, 2014