Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 2 Dose Levels of IW-3300 to Treat Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 weeks.

Location: SIMR (Sacramento/Valley Area)

Please contact: SIMR@sutterhealth.org about C3300-201 IC-BPS

Principal Investigator

Edward I. Levin, MD