Last reviewed · How we verify
Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
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.
Details
| Lead sponsor | Aquinox Pharmaceuticals (Canada) Inc. |
|---|---|
| Phase | PHASE2 |
| Status | TERMINATED |
| Enrolment | 3 |
| Start date | Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Jul 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Chronic Prostatitis
- Chronic Pelvic Pain Syndrome
Interventions
- AQX-1125 200 mg
- Placebo
Countries
Canada, United States