Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Status:
Terminated
Trial end date:
2018-07-17
Target enrollment:
Participant gender:
Summary
This is a randomized, multi-center, double-blind, parallel-group study, enrolling
approximately 100 male subjects diagnosed with CP/CPPS to evaluate the effect of 12-week
treatment with AQX-1125 (active drug) compared to placebo.
The subjects will be randomized to receive orally once-daily either AQX-1125 (200 mg) or
placebo in a 1:1 ratio across approximately 30 centers in North America (United States and
Canada). The study will consist of a screening period of up to 3 weeks, a 12-week treatment
period followed by a 4-week off drug safety follow-up period, and an ophthalmic safety
follow-up call at 3 months and visit at 6 months post last dose, for a total study duration
of about 41 weeks.