Knobias Clip Report (09-29-2008) CBRX
Submitted By Knobias ClipReport
CBRX: Phase II Trial Fails to Meet Primary Endpoint
By Fain Hughes, fhughes@knobias.com
Columbia Laboratories, Inc. (CBRX) announced results from its Phase II study of vaginally-administered lidocaine, which the Company is investigating for the prevention and treatment of dysmenorrhea. No treatment currently exists to prevent dysmenorrhea.
Seventy women with a history of moderate-to-severe dysmenorrhea participated in this first documented attempt to show prevention of uterine cramping and pain. This double-blind, placebo-controlled clinical trial used a cross-over design in which each subject received either the lidocaine product candidate or placebo in consecutive menstrual cycles and thus acted as her own control. The primary endpoint of the study was to show a difference between lidocaine and placebo in terms of the time-weighted average patient-assessed pain intensity over four treatment days. Data from the clinical trial did not show a significant difference between the pain scores for the lidocaine and placebo treatment cycles. Patients in the clinical trial were also asked to make a subjective assessment of the treatment at the end of each cycle, and to compare the first and second cycles to one another. While complete analysis of these secondary data is ongoing, top line data suggest a trend for patients to favor their lidocaine treatment cycle. The clinical trial did not reveal any significant adverse events and those adverse events that occurred were similar in both kind and frequency for lidocaine and placebo.
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