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Safety and Efficacy of the Buprenorphine Transdermal System in Subjects With Mod-to-Sev Osteoarthritis of Hip or Knee

2014-07-23 21:45:19 | BioPortfolio

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Description

Buprenorphine is a synthetic opioid analgesic with over twenty-five 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: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Osteoarthritis

Intervention

Buprenorphine transdermal delivery system

Location

Vista Medical Research
Mesa
Arizona
United States
85206

Status

Completed

Source

Purdue Pharma LP

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:45:19-0400

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The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and ...

Safety and Efficacy of Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Osteoarthritis Pain

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Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

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Medical and Biotech [MESH] Definitions

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.

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

The care of a fetus or newborn given before, during, and after delivery from the 28th week of gestation through the 7th day after delivery.

Delivery of the FETUS and PLACENTA under the care of an obstetrician or a health worker. Obstetric deliveries may involve physical, psychological, medical, or surgical interventions.

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