Treatment of Adults With Growth Hormone Deficiency

LG Life Sciences

Status and phase

Completed

Phase 3

Conditions

Adult Growth Hormone Deficiency

Pituitary Disorders

Treatments

Drug: growth hormone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00294619

BPLG-005

Details and patient eligibility

About

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.

Enrollment

147 patients

Sex

All

Ages

23 to 70 years old

Volunteers

No 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.