DARA BioSciences Announces New Analysis of Patient Self-Reported Diary Results in a Phase 2a Clinical Trial of KRN5500 in Patients With Cancer and Neuropathic Pain - Drugs.com

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DARA BioSciences Announces New Analysis of Patient Self-Reported Diary Results in a Phase 2a Clinical Trial of KRN5500 in Patients With Cancer and Neuropathic Pain

"....Previous analyses of the study data were based predominantly on patient-reported Numeric Rating Scale (NRS) pain scores collected by healthcare professionals in a clinic setting during weekly visits, whereas this new analysis focused specifically on self-reported daily pain scores from patients' diaries. Responders in this analysis were defined as patients attaining a clinically-meaningful (at least 20%) improvement in mean NRS scores from baseline within any given week. Of the 12 patients who received KRN5500 in this 19-patient trial, 7 (58%) were classified as responders. Further, 5 of the 7 (71%) showed sustained pain relief over several weeks. Of the 7 patients who received placebo, none were responders. Therefore, the new analysis showed a temporal consistency of pain relief in a larger fraction of patients than had been noted in the earlier analysis of weekly clinic-reported pain. These findings are impressive since patients enrolled in this proof-of-concept trial had unrelenting pain at baseline despite the concomitant use of other approved analgesic agents........