NCT00294619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

1.9 years

First QC Date

February 20, 2006

Last Update Submit

October 4, 2012

Conditions

Pituitary DisordersAdult Growth Hormone Deficiency

Keywords

Growth hormone deficiency

Outcome Measures

Primary Outcomes (1)

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

    26 weeks

Secondary Outcomes (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

    26 weeks

Study Arms (2)

LB03002

EXPERIMENTAL
Drug: growth hormone

Placebo

PLACEBO COMPARATOR
Drug: growth hormone

Interventions

growth hormoneDRUG

subcutaneous injection, once-weekly

LB03002Placebo

Eligibility Criteria

Age23 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health Sciences University

Portland, Oregon, United States

Location

MeSH Terms

Conditions

Pituitary DiseasesDwarfism, Pituitary

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Hypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarism

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • HJ Ji, PhD

    LG Life Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2006

First Posted

February 22, 2006

Study Start

April 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

US(1)