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Growth Hormone DeficiencyPhase 1NCT00455260

A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency

A Phase 1 study testing hGH-ViaDerm™ System (hGH or somatropin) and hGH-ViaDerm™ System in people with Growth Hormone Deficiency, run by Teva Neuroscience, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to examine the safety, tolerability and pharmacokinetics of transdermal delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult patients with Growth Hormone Deficiency Syndrome. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Growth Hormone Deficiency
What is being tested?
hGH-ViaDerm™ System (hGH or somatropin) and hGH-ViaDerm™ System
Type of treatment
Medical device
How many people
60 participants
Where
No sites listed yet
Study dates
Apr 2007to Oct 2007
Phase
Phase 1
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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Ages Eligible for Study: 20 Years - 60 Years, Genders Eligible for Study: Both
  • Clinical diagnosis of Adult Growth Hormone Deficiency (AGHD) meeting one of the following criteria:
  • Three or more additional pituitary hormone deficiencies, based on well documented medical history from up to 10 years prior to screening, and/or serum IGF-1 levels below 2 SD from normal level, measured up to 4 months prior to screening.
  • One or two additional pituitary hormone deficiencies with one GH stimulating test performed within 10 years prior to screening: Insulin Tolerance test with GH levels less than 5.1 µg/L or ARG-GHRH with GH levels less than 4.1 µg/L.
  • Isolated GH deficient subjects with two well-documented GH stimulating tests performed within 10 years prior to screening. Insulin Tolerance test with GH levels less than 5.1 µg/L or ARG-GHRH with GH levels less than 4.1 µg/L.
  • In childhood onset AGHD, confirmation of GHD following attainment of full height.
  • Subjects using hormone replacement therapy for additional pituitary deficits must be on an optimized treatment regimen for at least three months prior to screening.
  • Willing and able to provide written informed consent prior to performing any study procedures.

Who cannot join

  • GH therapy within one month prior to study entry.
  • For female subjects: pregnancy or lactation or use of oral contraception or unacceptable method of contraception throughout the study.
  • Active acromegaly in the last 5 years.
  • Carpal tunnel syndrome.
  • Prader-Willi syndrome.
  • Active Cushing's syndrome within the last 12 months.
Show all 27Show fewer
  • Non-compliance for upper arm SC injection or patch application.
  • Skin color or tattoo that would not enable detection of erythema.
  • Upper extremities with skin marks, bruises, cuts, abrasions on the upper arm.
  • Dense and dark hair growth on upper extremities.
  • History of skin hypersensitivity and/or allergies.
  • Known hypersensitivity to somatropin or mannitol
  • Evidence of active malignancy.
  • Previous use of chemotherapy, immunosuppressive or radiation therapy, except for treatment of pituitary disease.
  • Serum glucose (fasting) > 126 mg/dl.
  • Known or suspected HIV-positive subjects or subjects with advanced diseases such as AIDS, Hepatitis C, Hepatitis B or tuberculosis.
  • Subjects who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include cardiovascular, vascular, pulmonary, hepatic, renal, or neurological disease, as determined by medical history, physical examination, laboratory tests or ECG.
  • BMI < 19 and ≥ 35 kg/m2.
  • Weight reducing drugs or appetite suppressants.
  • Estrogen replacement therapy except transdermal patch.
  • Any psychological condition which may influence the compliance with the study requirements.
  • Unstabilized antidepressant or antipsychotic medication therapy within 2 months prior to screening.
  • Subjects with a known history of alcohol abuse.
  • Subjects who received blood or plasma derivatives in the three months preceding screening.
  • Subjects who donated blood in the preceding three months of screening or intend to make a blood donation during the study, or within the three months following the study completion.
  • Subjects who have participated in another clinical study of any kind (drug or device) in the one month prior to screening.
  • Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone Deficiency

This study aims to examine the safety, tolerability and pharmacokinetics of transdermal delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult patients with Growth Hormone Deficiency Syndrome.

Being tested
hGH-ViaDerm™ System (hGH or somatropin), hGH-ViaDerm™ System
Medical subject headings
Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hGH-ViaDerm™ System (hGH or somatropin)Drug

    transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day)

  • hGH-ViaDerm™ SystemDevice

    The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin).

    The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AE

    Measured: 36 days

  2. Laboratory values

    Measured: 36 days

  3. Vital signs

    Measured: 36 days

  4. ECG

    Measured: 36 days

  5. Patch application site reaction: Skin irritation- erythema, edema

    Measured: 36 days

  6. Patch application site reaction: Pain - Visual Analogue Scale

    Measured: 36 days

  7. Proportion of subjects (%) who discontinue the study

    Measured: 36 days

  8. Proportion of subjects (%) who discontinue the study due to AEs

    Measured: 36 days

  9. Pharmacokinetics: Somatropin exposure including Cmax, Tmax, AUC, AUC, Ke, and T1/2.

    Measured: 36 days

  10. Pharmacodynamics: Human IGF-1 levels and AUC.

    Measured: 36 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionOct 2007

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00455260
Sponsor's protocol ID
GH-VD-102
Status last verified
Apr 2009
First submitted
2 Apr 2007
Last updated
2 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hGH-ViaDerm™ System (hGH or somatropin) and hGH-ViaDerm™ System in people with Growth Hormone Deficiency, run by Teva Neuroscience, Inc..

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 8 inclusion and 27 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 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

AE (time frame: 36 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00455260.

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 2 Sep 2013.

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