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Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

2014-08-27 03:13:35 | BioPortfolio

Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of BTDS. Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose (up to BTDS 20 mcg/h) depending on adequate pain relief and tolerability.

Description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Low Back Pain

Intervention

Buprenorphine transdermal patch, Buprenorphine transdermal patch, Buprenorphine transdermal patch

Location

Arthritis Clinical Intervention Program
Birmingham
Alabama
United States
35249

Status

Terminated

Source

Purdue Pharma LP

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:35-0400

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Medical and Biotech [MESH] Definitions

A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.

A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESIC with naloxone, a NARCOTIC ANTAGONIST to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIATE SUBSTITUTION THERAPY.

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

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.

Removal and examination of tissue obtained through a transdermal needle inserted into the specific region, organ, or tissue being analyzed.

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