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.