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• W2165207150 abstract "You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology I1 Apr 20101508 TANEZUMAB REDUCES PAIN AND URGENCY IN INTERSTITIAL CYSTITIS: RESULTS OF A PHASE 2 TRIAL Robert Evans, Robert Moldwin, Nandini Cossons, Amanda Darekar, David Scholfield, and Ian Mills Robert EvansRobert Evans Greensboro, NC More articles by this author , Robert MoldwinRobert Moldwin New Hyde Park, NY More articles by this author , Nandini CossonsNandini Cossons Sandwich, United Kingdom More articles by this author , Amanda DarekarAmanda Darekar Sandwich, United Kingdom More articles by this author , David ScholfieldDavid Scholfield Sandwich, United Kingdom More articles by this author , and Ian MillsIan Mills Sandwich, United Kingdom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1246AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Tanezumab, a humanized antibody specific for nerve growth factor, reduces pain in conditions such as osteoarthritis of the knee and low back pain. A phase 2 trial was performed to evaluate the safety and efficacy of tanezumab 200 ug/kg for the treatment of interstitial cystitis (IC). METHODS This was a randomized, double-blind, placebo-controlled study in patients with moderate to severe IC (O'Leary-Sant Interstitial Cystitis Symptom Index [ICSI] score of >=7 and Pelvic Pain and Urgency/Frequency [PUF] symptom score of >=13). After recording daily pain scores over 7 days and completing a daily urinary symptom diary for 3 of those days, patients with a mean pain intensity score of >=4 on an 11-point (0-10) Numeric Rating Scale (NRS) and a mean micturition frequency of >=8 per 24 hours, were randomized to receive a single dose of either tanezumab 200 ug/kg or placebo IV. During the 16 weeks post-treatment, patients attended 5 study visits (weeks 2, 4, 6, 10, 16). Patients were asked to record daily pain scores (using the 11-point NRS) for the 7 days prior to attending each study visit, and also to complete a daily urinary symptom diary for 3 of those days. The primary endpoint was change from baseline in average daily pain score at Week 6 as measured by the 11-point NRS. Secondary endpoints included changes in urgency episode frequency per 24 hours, micturition frequency per 24 hours, and mean voided volume (MVV) per micturition derived from the 3-day urinary symptom diary. Adverse events (AE) were monitored throughout the study. RESULTS Of the 65 patients enrolled in the study, 34 (91% female; mean age of 43.5 years) received tanezumab 200 ug/kg, 30 (87% female; mean age of 45.2 years) received placebo, and 1 patient did not receive treatment. At Week 6, tanezumab produced clinically significant improvements in average daily pain score and urgency episode frequency per 24 hours versus placebo, but had no clinically significant effect on micturition frequency per 24 hours or MVV per micturition versus placebo (Table 1). Overall, 47% of tanezumab patients and 40% of placebo patients had a treatment-related AE, the most common of which were paraesthesia (tanezumab: 15%; placebo 3%) and headache (12%; 7%). CONCLUSIONS Tanezumab 200 ug/kg can effectively reduce both pain and urgency episode frequency in patients with IC and appears safe and well tolerated. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e581 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Robert Evans Greensboro, NC More articles by this author Robert Moldwin New Hyde Park, NY More articles by this author Nandini Cossons Sandwich, United Kingdom More articles by this author Amanda Darekar Sandwich, United Kingdom More articles by this author David Scholfield Sandwich, United Kingdom More articles by this author Ian Mills Sandwich, United Kingdom More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ..." @default.
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• W2165207150 title "1508 TANEZUMAB REDUCES PAIN AND URGENCY IN INTERSTITIAL CYSTITIS: RESULTS OF A PHASE 2 TRIAL" @default.
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