Investigation of a Ca 2+ Channel α2δ Ligand for the Treatment of Interstitial Cystitis: Results of a Randomized, Double-Blind, Placebo Controlled Phase II Trial
2012; Lippincott Williams & Wilkins; Volume: 188; Issue: 3 Linguagem: Inglês
10.1016/j.juro.2012.05.010
ISSN1527-3792
AutoresJ. Curtis Nickel, Anna Crossland, Edward L. Davis, François Haab, Ian Mills, Eric Rovner, David Scholfield, Tim Crook,
Tópico(s)Sexual function and dysfunction studies
ResumoNo AccessJournal of UrologyAdult Urology1 Sep 2012Investigation of a Ca2+ Channel α2δ Ligand for the Treatment of Interstitial Cystitis: Results of a Randomized, Double-Blind, Placebo Controlled Phase II Trial J. Curtis Nickel, Anna Crossland, Edward Davis, François Haab, Ian W. Mills, Eric Rovner, David Scholfield, and Tim Crook J. Curtis NickelJ. Curtis Nickel Department of Urology, Queen's University, Kingston, Ontario, Canada Financial interest and/or other relationship with Pfizer, Johnson & Johnson, Watson, Taris, GSK, Astellas, Trillium Therapeutics, Farr Labs, Cernelle and Eli Lilly. More articles by this author , Anna CrosslandAnna Crossland Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. More articles by this author , Edward DavisEdward Davis Citrus Valley Medical Research, Inc., Glendora, California More articles by this author , François HaabFrançois Haab Service d'Urologie, Hospital Tenon, Paris, France More articles by this author , Ian W. MillsIan W. Mills Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. More articles by this author , Eric RovnerEric Rovner Department of Urology, Medical University of South Carolina, Charleston, South Carolina Financial interest and/or other relationship with Pfizer. More articles by this author , David ScholfieldDavid Scholfield Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. More articles by this author , and Tim CrookTim Crook Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.05.010AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We investigated PD-0299685, a Ca2+ channel α2δ ligand, for interstitial cystitis pain in a randomized, double-blind, placebo controlled phase IIa study. Materials and Methods: Patients with interstitial cystitis/bladder pain syndrome received 30 or 60 mg PD-0299685 daily or placebo for 12 weeks. Primary end points were change in average daily worst pain severity score (on an 11-point numerical rating scale) and change in Interstitial Cystitis Symptom Index score from baseline to week 12. Secondary end points included global response assessment, micturition and urgency episode frequency per 24 hours and mean voided volume per micturition. Incidence of adverse events was also assessed. Results: Of 161 patients 54 received 30 mg PD-0299685 daily, 55 received 60 mg PD-0299685 daily and 52 received placebo. At week 12 the 60 mg dose produced a clinically significant reduction in daily worst pain severity score from baseline compared to placebo (treatment difference [90% CI] –0.82 [–1.72, 0.08]). A greater proportion of patients taking 60 mg PD-0299685 daily demonstrated improvement in global response assessment. PD-0299685 had no clinically significant effect on the Interstitial Cystitis Symptom Index score or urinary end points. More patients discontinued due to treatment related adverse events with 30 or 60 mg PD-0299685 daily than with the placebo. Conclusions: PD-0299685 failed to demonstrate positive proof of concept for the treatment of pain and other urinary end points associated with interstitial cystitis/bladder pain syndrome. References 1 : How do patients with interstitial cystitis present?. J Urol2001; 166: 2118. 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Google Scholar © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byNickel J, Moldwin R, Hanno P, Dmochowski R, Peters K, Payne C and Wein A (2019) Targeting the SHIP1 Pathway Fails to Show Treatment Benefit in Interstitial Cystitis/Bladder Pain Syndrome: Lessons Learned from Evaluating Potentially Effective Therapies in This Enigmatic SyndromeJournal of Urology, VOL. 202, NO. 2, (301-308), Online publication date: 1-Aug-2019.Nickel J, Egerdie B, Davis E, Evans R, Mackenzie L and Shrewsbury S (2018) A Phase II Study of the Efficacy and Safety of the Novel Oral SHIP1 Activator AQX-1125 in Subjects with Moderate to Severe Interstitial Cystitis/Bladder Pain SyndromeJournal of Urology, VOL. 196, NO. 3, (747-754), Online publication date: 1-Sep-2016.Schaeffer E (2018) Re: Continuous Intravesical Lidocaine Treatment for Interstitial Cystitis/Bladder Pain Syndrome: Safety and Efficacy of a New Drug Delivery DeviceJournal of Urology, VOL. 189, NO. 6, (2131-2131), Online publication date: 1-Jun-2013.Steers W (2018) This Month in Adult UrologyJournal of Urology, VOL. 188, NO. 3, (687-688), Online publication date: 1-Sep-2012. Volume 188Issue 3September 2012Page: 817-823Supplementary Materials Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.Keywordsinterstitialvoltage gated calcium channel subunit Ca alpha2delta-1humanclinical trialcystitispainAcknowledgmentsThe following principal investigators and their sub-investigators, study coordinators and other site staff enrolled patients in the study: Dr. Gary Steinhoff, Dr. Joseph A. Zadra, Dr. Jack Barkin, Dr. Le Mai Tu, Dr. Corey G. Anderson, Dr. Beatrice Cuzin, Dr. Sebastien Vincendeau, Christian Saussine, Dr. Jerome Rigaud, Dr. Ursula Peschers, Sven Rugge, Dr. Mikael Leppilahti, Dr. Markku Vaarala, Jukka Sairanen, Prof. Teuvo Tammela, Dr. Leonid Kotkin, Dr. Mickey M. Karram, Dr. Harriette M. Scarpero, Dr. Ricky Lee Evans, Dr. Charles Fox White Jr., Dr. Joergen Nordling, Dr. Phillip Madonia, Dr. Evan Robert Goldfischer, Dr. David Oselinsky, Dr. Mitchell Douglas Efros, Dr. Jill Marie Peters-Gee, Dr. Edward Lee Davis, Dr. Joseph D. Parkhurst, Prof. Pierre Costa, Dr. Markku Multanen, Dr. Lane Jay Mercer, Dr. Russell Blair Egerdie, Dr. James Lee Bailen, Dr. Terri Ann Oskin, Dr. Bernard Lee Hertzman, Dr. Marianne Gay Rochester, Dr. Henry David Mitcheson and Dr. Kevin James Cline. In addition to the site monitors and other study team members, Pfizer study managers Joy Nelson, Titilayo Majekodunmi and Marina Kiseleva assisted with the study.MetricsAuthor Information J. Curtis Nickel Department of Urology, Queen's University, Kingston, Ontario, Canada Financial interest and/or other relationship with Pfizer, Johnson & Johnson, Watson, Taris, GSK, Astellas, Trillium Therapeutics, Farr Labs, Cernelle and Eli Lilly. More articles by this author Anna Crossland Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. More articles by this author Edward Davis Citrus Valley Medical Research, Inc., Glendora, California More articles by this author François Haab Service d'Urologie, Hospital Tenon, Paris, France More articles by this author Ian W. Mills Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. More articles by this author Eric Rovner Department of Urology, Medical University of South Carolina, Charleston, South Carolina Financial interest and/or other relationship with Pfizer. More articles by this author David Scholfield Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. More articles by this author Tim Crook Pfizer Inc, Sandwich, Kent, United Kingdom Financial interest and/or other relationship with Pfizer. 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