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"This pilot methodology study was designed to test the feasibility andreliability of the OSQ," reported Dr. Bernard Schachtel, Chief ScientificOfficer at Charleston Labs. "All patients used the OSQ before and atintervals after ingesting different opioid drugs to indicate the presence andseverity of symptoms caused by these medications.
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"Using the OSQ prospectively, showing natural progression of opioid sideeffects," Dr. Schachtel continued, "patients detected different symptoms, notjust nausea or vomiting, in good accordance with conventional methods,occasionally with better sensitivity. We will be presenting the final resultsfrom this version of the OSQ and other measurement instruments to ourScientific Advisory Board and the clinical investigators for their review andinput before completing the protocol for our full-sized clinical trial."
This methodology study was conducted in preparation for Charleston'sstudies on patients who may experience OINV, the target indication forCharleston's first opioid drug, CL-108. Arrangements are being made withclinical investigators at major universities and research sites in the US toparticipate in a multi-centered double-blind, randomized, placebo-controlled,multiple-dose safety and efficacy study on over 1,000 patients withpost-operative pain. The purpose of this Phase III study is to evaluateCL-108 for relief of acute moderately severe or severe pain and the reductionor elimination of OINV.
All clinical studies for Charleston Laboratories are being overseen bySRC, Inc., a contract research organization based in Jupiter, Florida, whichspecializes in clinical trials on patients' symptoms (such as nausea).
About Charleston Laboratories, Inc
Charleston Laboratories Inc, headquartered in Charleston, SC, is aprivately funded specialty pharmaceutical company developing andcommercializing opioid drugs with minimal or no opioid-induced nausea andvomiting (OINV). Charleston Laboratories intends to enter into discovery andcommercialization alliances with partners motivated to introduce novel paintherapies that eliminate or significantly reduce nausea and vomiting.
SOURCE Charleston Laboratories, Inc
