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A New Medical Research Study for Women with Interstitial Cystitis/Bladder Pain Syndrome

Afferent Pharmaceuticals, Inc. is conducting a medical research study at 18 research study centers in the US for women with moderate to severe Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). The purpose of this study is to determine the safety, effectiveness and tolerability of an investigational medication (called AF-219) for the treatment of IC/BPS. AF-219 may relieve sensitive bladder nerves by blocking P2X3 receptors. As a result, AF-219 could play a role in the treatment of IC/BPS symptoms, including pain. It is unknown if AF-219 will relieve IC/BPS symptoms since this is the first research study of AF-219 in IC/BPS.

AF-219 is a tablet that is taken twice daily and will be compared to a placebo tablet that looks similar to the investigational medication, but contains no active ingredient. In order to qualify for this research study, you must be a woman between 18 and 80 years of age and you must have been experiencing bladder pain, pressure or discomfort, along with frequent urination, for at least 6 months. Additional criteria will be discussed with you by the study doctor
at the research study center. Those who qualify for this research study can expect their participation to involve up to 7 visits to the study center and one phone call over a period of 9 weeks. Qualified participants receive all study-related care and study medication at no cost, plus compensation for time and travel. You are not eligible for the study if you are pregnant or breastfeeding.

The following research study centers will be enrolling participants:

  • Alabama, Birmingham – Brookwood Medical Center – Contact Catherine McDaniel 205-877- 2786
  • California, San Diego – SD URO-Research – Contact Patti Sanchez-Emery 619-299-6500
  • Connecticut, Farmington – Women’s Health Specialty Care – Contact Madeline Vasquez 860-678-7300, ext. 15
  • Florida, Boynton Beach – Visions Clinical Research – Contact Casey Smith 561-964-7880
  • Florida, Daytona Beach – Atlantic Urological Associates – Contact Jeannie McMillan 386-239-8535
  • Florida, Winter Haven – Winter Haven LLC – Contact Letty Rivera 877-762-2906
  • Indiana, Jeffersonville – Metropolitan Urology PSC – Contact Chris Dallas 812-206-8164
  • Maryland, Annapolis – Anne Arundel Urology, P.A. – Contact Elizabeth Dantonio 410-266-8049, ext. 143 or Renee Wells, ext. 148
  • Michigan, Ann Arbor – Univ. of MI Health System, Dept. of Urology – Contact Jana Creps 734-764-9308 (not yet enrolling)
  • Michigan, Kalamazoo – Beyer Research – Contact Lucy Pelletier 269-372-7800
  • New York, Hyde Park – The Arthur Smith Institute for Urology – Contact Monica Johnson 516-734-8515
  • New York, Poughkeepsie – Premier Medical Group of Hudson Valley PC – Contact Alexa Markiewicz 845-473-5051
  • North Carolina, Raleigh – Associated Urologists of North Carolina – Contact Jan Vickerson 919-782-1255
  • North Carolina, Raleigh – Wake Research Associates, LLC – Contact Dhara Vaghani or Briget Smallwood-Hurdle 919-781-2514
  • North Carolina, Salisbury – PMG Research of Salisbury – Contact Stephenie Barnhardt 704-647-9913
  • North Carolina, Winston Salem – Wake Forest Univ. Health Sciences – Contact Janet Shuping 336-716-2612 (not yet enrolling)
  • Texas, Desoto – Thomas Lane Dykes, Jr., MD – Contact Andy Longoria 214-861-5170
  • Washington, Mountlake Terrace – Integrity Medical Research, LLC – Contact Anna Fiero 425-275-0680

More centers will be added in the future. To find out more information about this research study,
please go to www.clinicaltrials.gov.

By | 2017-01-18T12:09:55+00:00 June 5th, 2012|Clinical Trials|Comments Off on A New Medical Research Study for Women with Interstitial Cystitis/Bladder Pain Syndrome

About the Author:

My Google Profile+ Jill Heidi Osborne is the president and founder of the Interstitial Cystitis Network, a health education company dedicated to interstitial cystitis, bladder pain syndrome and other pelvic pain disorders. As the editor and lead author of the ICN and the IC Optimist magazine, Jill is proud of the academic recognition that her website has achieved. The University of London rated the ICN as the top IC website for accuracy, credibility, readability and quality. (Int Urogynecol J - April 2013). Harvard Medical School rated both Medscape and the ICN as the top two websites dedicated to IC. (Urology - Sept 11). Jill currently serves on the Congressionally Directed Medical Research Panel (US Army) where she collaborates with researchers to evaluate new IC research studies for possible funding. Jill has conducted and/or collaborates on a variety of IC research studies on new therapeutics, pain care, sexuality, the use of medical marijuana, menopause and the cost of treatments, shining a light on issues that influence patient quality of life. An IC support group leader and national spokesperson for the past 20 years, she has represented the IC community on radio, TV shows, at medical conferences. She has written hundreds of articles on IC and its related conditions. With a Bachelors Degree in Pharmacology and a Masters in Psychology, Jill was named Presidential Management Intern (aka Fellowship) while in graduate school. (She was unable to earn her PhD due to the onset of her IC.) She spends the majority of her time providing WELLNESS COACHING for patients in need and developing new, internet based educational and support tools for IC patients, including the “Living with IC” video series currently on YouTube and the ICN Food List smartphone app! Jill was diagnosed with IC at the age of 32 but first showed symptoms at the age of 12.