Charleston Laboratories, Inc, an emerging specialty pharmaceutical company dedicated to reducing opioid-induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced preliminary findings from its development and testing of an Opioid Symptoms Questionnaire, or OSQ, which will be used in Charleston’s clinical trials.
“This pilot methodology study was designed to test the feasibility and reliability of the OSQ,” reported Dr. Bernard Schachtel, Chief Scientific Officer at Charleston Labs. “All patients used the OSQ before and at intervals after ingesting different opioid drugs to indicate the presence and severity of symptoms caused by these medications.
“Using the OSQ prospectively, showing natural progression of opioid side effects,” Dr. Schachtel continued, “patients detected different symptoms, not just nausea or vomiting, in good accordance with conventional methods, occasionally with better sensitivity. We will be presenting the final results from this version of the OSQ and other measurement instruments to our Scientific Advisory Board and the clinical investigators for their review and input before completing the protocol for our full-sized clinical trial.”
This methodology study was conducted in preparation for Charleston’s studies on patients who may experience OINV, the target indication for Charleston’s first opioid drug, CL-108. Arrangements are being made with clinical investigators at major universities and research sites in the US to participate in a multi-centered double-blind, randomized, placebo-controlled, multiple- dose safety and efficacy study on over 1,000 patients with post-operative pain. The purpose of this Phase III study is to evaluate CL-108 for relief of acute moderately severe or severe pain and the reduction or elimination of OINV.
All clinical studies for Charleston Laboratories are being overseen by SRC, Inc., a contract research organization based in Jupiter, Florida, which specializes in clinical trials on patients’ symptoms (such as nausea).