NCT03500159

Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Efficacy and Safety of AQX-1125 (200 mg) in Male Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Aquinox Pharmaceuticals (Canada) Inc. · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Prostatitis
• Chronic Pelvic Pain Syndrome

Interventions

Type	Name	Description
DRUG	AQX-1125 200 mg	Synthetic SHIP1 activator
DRUG	Placebo	Appearance and weight matched tablets without the active product ingredient

Timeline

• Start date: 2018-04-18
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2018-04-17
• Last updated: 2019-01-09
• Results posted: 2019-01-09

Locations

27 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study