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Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury

2014-08-27 03:16:28 | BioPortfolio

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Thermal Injury Pain

Intervention

R475, Placebo

Location

Tampa
Florida
United States

Status

Terminated

Source

Regeneron Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:28-0400

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Medical and Biotech [MESH] Definitions

Sensing of noxious mechanical, thermal or chemical stimuli by NOCICEPTORS. It is the sensory component of visceral and tissue pain (NOCICEPTIVE PAIN).

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Conditions characterized by pain involving an extremity or other body region, HYPERESTHESIA, and localized autonomic dysfunction following injury to soft tissue or nerve. The pain is usually associated with ERYTHEMA; SKIN TEMPERATURE changes, abnormal sudomotor activity (i.e., changes in sweating due to altered sympathetic innervation) or edema. The degree of pain and other manifestations is out of proportion to that expected from the inciting event. Two subtypes of this condition have been described: type I; (REFLEX SYMPATHETIC DYSTROPHY) and type II; (CAUSALGIA). (From Pain 1995 Oct;63(1):127-33)

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A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

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