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ARTICLE | Clinical News

Charleston's CL-108 meets in Phase III trial pain trial

October 30, 2013 12:53 AM UTC

Charleston Laboratories Inc. (Jupiter, Fla.) stopped a Phase III trial early after an interim analysis showed CL-108 met the co-primary endpoints of reducing pain and opioid-induced nausea and vomiting (OINV). An interim analysis by the independent DMC showed oral CL-108 reduced the occurrence and severity of OINV over 24 hours vs. generic hydrocodone/acetaminophen and also improved pain relief from baseline over 24 hours vs. placebo (p<0.01 for both). The double-blind, U.S. trial enrolled 466 patients with moderate to severe acute pain following surgical removal of impacted third molars. ...