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| Sponsor: | Teva Neuroscience, Inc. |
|---|---|
| Collaborators: |
Teva Pharmaceutical Industries TransPharma Medical |
| Information provided by: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00455260 |
Purpose
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 |
|---|---|---|
|
Growth Hormone Deficiency |
Drug: hGH-ViaDerm™ System (hGH or somatropin) Device: hGH-ViaDerm™ System |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Siyu Liu, Vice President, North American Innovative Research and Development and Head of Global Clinical Operations, Teva Neuroscience |
| ClinicalTrials.gov Identifier: | NCT00455260 History of Changes |
| Other Study ID Numbers: | GH-VD-102 |
| Study First Received: | April 2, 2007 |
| Last Updated: | April 11, 2011 |
| Health Authority: | Israel: Ministry of Health; Ukraine: Ministry of Health |
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Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine |
Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |