Pituitary DisordersPhase 3NCT00294619
Treatment of Adults With Growth Hormone Deficiency
A Phase 3 study testing growth hormone in people with Pituitary Disorders and Adult Growth Hormone Deficiency, run by LG Life Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 23 to 70 years
- Conditions the study is for
- Pituitary Disorders, Adult Growth Hormone Deficiency
- What is being tested?
- growth hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- growth hormone
- Keywords
- Growth hormone deficiency
- Medical subject headings
- Pituitary Diseases, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth hormoneDrug
subcutaneous injection, once-weekly
| Study group | Role | What they receive |
|---|---|---|
| LB03002 | Experimental | Not described Receives: Drug: growth hormone |
| Placebo | Placebo comparator | Not described Receives: Drug: growth hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fat Mass at the end of 26-week treatment from baseline
Measured: 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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioPartners GmbH
- Responsible party
- Sponsor
- Investigators
- HJ Ji, PhD, Study chair, LG Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294619
- Sponsor's protocol ID
- BPLG-005
- Status last verified
- Oct 2012
- First submitted
- 20 Feb 2006
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00294619
- Acronym / sponsor ID
- BPLG-005
- Keywords
- Growth hormone deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- BioPartners GmbH
- Study start
- Apr 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LB03002 | Experimental | Drug: growth hormone |
| Placebo | Placebo comparator | Drug: growth hormone |
Who may qualify
- Ages
- 23 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| growth hormonesubcutaneous injection, once-weekly | Drug | LB03002, Placebo |
Primary outcome
Changes in Fat Mass at the end of 26-week treatment from baseline
Time frame: 26 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HJ Ji, PhD study chair
LG Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing growth hormone in people with Pituitary Disorders and Adult Growth Hormone Deficiency, run by LG Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fat Mass at the end of 26-week treatment from baseline (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.