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Urology Research

Study Title: LEADERSHIP 301 Trial:  A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by 40 Week Extension Periods.  Protocol AQX-1125-301  (NCT# 02858453)

Study Purpose:  This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome.  Participants will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the study.  After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1152 for 52 weeks.

Principal Investigator:  Puneet Sindhwani, M.D.

Study Coordinator: For more information contact Julie Harris, RN or call 419.383.6925.



Last Updated: 7/11/17