Relative Bioavailability of a Fentanyl Patch
Summary
Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pain
Intervention
Fentanyl patch 25 ug/nr Sandoz, Duragesic
Status
Completed
Source
Sandoz Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00857753
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Patch-clamp Techniques
An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.
Fentanyl
A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)
Transdermal Patch
A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.
Patch Tests
Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.
Pain, Referred
A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.
Clinical Trials
The objective of this study is to assess the safety of treatment with Duragesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50, 75 and 100...
The objective of this study is to assess the safety and clinical utility of Duragesic® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the t...
The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Myl...
Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain
The purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (na...
The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc....
PubMed Articles
PURPOSE: Opioids are used in controlling several types of pain. This study was designed to evaluate the efficacy and safety of the fentanyl transdermal patch-type system (Durogesic(R) D-TRANS). METHOD...
Bellei, E., Roncada, P., Pisoni, L., Joechler, M., Zaghini, A. The use of fentanyl-patch in dogs undergoing spinal surgery: plasma concentrations and analgesic efficacy. J. vet. Pharmacol. Therap. doi...
The purpose of this study was to investigate the effect of fentanyl on analgesic properties and respiratory responses during an epidural procedure. Sixty patients premedicated with oral brotizolam 0.2...
Fentanyl for breakthrough pain: a systematic review.
The purpose of this article is to systematically review the use of fentanyl as an analgesic for breakthrough pain. This article found that the oral transmucosal fentanyl (OTFC) had a quicker onset to...
BACKGROUND: Although acetaminophen has been used widely and is well tolerated in children, its efficacy and safety have not been clarified when combined with an opioid in intravenous parent-/nurse-con...
