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Sponsors and Collaborators: |
Teva Pharmaceutical Industries TransPharma Medical |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00455260 |
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.
Condition | Intervention | Phase |
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Growth Hormone Deficiency |
Drug: hGH-ViaDerm™ System (hGH or somatropin) Device: hGH-ViaDerm™ System |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy 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 |
Enrollment: | 60 |
Study Start Date: | April 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
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.
The transdermal hGH patch is applied to the skin surface which has been pre-treated with the handheld ViaDerm device. The ViaDerm device uses radiofrequency signal to generate microchannels in the outer layer of the skin enabling transdermal hGH delivery. The study hypothesis states that the hGH ViaDerm System will facilitate systemic delivery of hGH with a similar safety profile and substantially reduced discomfort as compared to the conventional subcutaneous injection route of administration.
Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Israel | |
Rabin Medical Center, Campus Beilinson | |
Petach Tikva, Israel, 49100 | |
Hadassah University Hospital, Ein Kerem | |
Jerusalem, Israel, 91120 | |
Ukraine | |
Institute of Endocrinology and Metabolism, Academy of Medical Science of Ukraine | |
Kiev, Ukraine, 04114 |
Study Director: | Noa Avisar, PhD | Teva Pharmaceutical Industries |
Responsible Party: | Teva Neuroscience ( Siyu Liu, Vice President, North American Innovative Research and Development and Head of Global Clinical Operations ) |
Study ID Numbers: | GH-VD-102 |
Study First Received: | April 2, 2007 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00455260 History of Changes |
Health Authority: | Israel: Ministry of Health; Ukraine: Ministry of Health |
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Hypopituitary Dwarfism Pituitary Diseases Endocrine System Diseases Central Nervous System Diseases Dwarfism, Pituitary |
Brain Diseases Hormones Bone Diseases Musculoskeletal Diseases Hypopituitarism Growth Hormone Deficiency Bone Diseases, Developmental Endocrinopathy |
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Nervous System Diseases Endocrine System Diseases Central Nervous System Diseases |
Dwarfism, Pituitary Brain Diseases Bone Diseases Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental |