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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00294619
Other study ID # BPLG-005
Secondary ID
Status Completed
Phase Phase 3
First received February 20, 2006
Last updated October 4, 2012
Start date April 2006
Est. completion date March 2008

Study information

Verified date October 2012
Source LG Life Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 23 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
growth hormone
subcutaneous injection, once-weekly

Locations

Country Name City State
United States Oregon Health Sciences University Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
LG Life Sciences BioPartners GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Fat Mass at the end of 26-week treatment from baseline 26 weeks No
Secondary 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 Yes
See also
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