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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Prostatitis, Chronic Pelvic Pain Syndrome

In brief

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.

Key facts

Study ID

NCT03500159

Run by

Aquinox Pharmaceuticals (Canada) Inc.

People needed

3

Starts

2018-04-18

Expected to finish

2018-07-17

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent and the willingness and ability to comply with all aspects of the study requirements
• Males, ≥18 and ≤80 years of age at Screening Visit 1
• Have pain or discomfort in the pelvic region for at least 3 months in the last 6 months, in the absence of a urinary tract infection or other pelvic/urological cause, and have a physician diagnosis of CP/CPPS (NIH Prostatitis Category III)
• Subjects must agree to use a condom for sexual intercourse from Screening Visit 1 until at least 90 days after the last dose of study drug, unless they have been surgically sterilized (vasectomy) for a minimum of 6 months
• Must be capable of voiding independently for 30 days prior to screening

You may not qualify if…

• Diagnosis of NIH Prostatitis Categories I (acute prostatitis) or II (chronic bacterial) prostatitis
• Diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) with symptoms of pain, pressure, or discomfort perceived to be related to the bladder, and associated lower urinary symptoms for >6 weeks in the absence of infection or other identifiable causes
• Relief of pelvic pain after voiding
• Post-void residual volume >150 mL
• Have had an unresolved (positive bacterial urine culture) urinary tract infection within 8 weeks (inclusive) prior to Screening Visit 1
• History of previous prostate or bladder intervention within 1 month of Screening Visit 1, history of microwave therapy, transurethral resection of the prostate, transurethral radiofrequency thermotherapy, transurethral incision of the prostate, transurethral needle ablation, transurethral laser vaporization of the prostate, Urolift®, Rezum, and other urological interventions within 6 months of Screening Visit 1
• Unilateral testicular or scrotal pain as the sole symptom of CP/CPPS
• Ongoing, symptomatic urethral stricture disease
• Neurologic disease or disorder affecting the bladder, ability to void spontaneously, or directly contributing to urinary symptoms (e.g., multiple sclerosis, autonomic neuropathy)
• Severe, excruciating pain during rectal exam (i.e. an "inability to perform the exam")
• History of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years
• Any prior history of pelvic cancer (e.g., colorectal, genitourinary) or treatment (radiation or chemotherapy) thereof
• Major surgery within 3 months prior to Screening Visit 1
• Have any other condition/disease which, in the opinion of the Investigator, could compromise subject safety or interfere with the subject's participation in the study or in the evaluation of the study results.

Where it is running

• Site 1026 — Homewood, Alabama, United States
• Site 1010 — Mobile, Alabama, United States
• Site 1004 — Tucson, Arizona, United States
• Site 1028 — Laguna Hills, California, United States
• Site 1018 — Los Alamitos, California, United States
• Site 1016 — Los Angeles, California, United States
• Site 1020 — Los Angeles, California, United States
• Site 1027 — New Port Richey, Florida, United States
• Site 1013 — Coeur d'Alene, Idaho, United States
• Site 1015 — Springfield, Illinois, United States
• Site 1023 — Jeffersonville, Indiana, United States
• Site 1014 — West Des Moines, Iowa, United States
• Site 1012 — Shreveport, Louisiana, United States
• Site 1002 — Royal Oak, Michigan, United States
• Site 1011 — Albuquerque, New Mexico, United States
• Site 1009 — Lake Success, New York, United States
• Site 1021 — Charlotte, North Carolina, United States
• Site 1008 — Raleigh, North Carolina, United States
• Site 1019 — Wilmington, North Carolina, United States
• Site 1001 — Cleveland, Ohio, United States
• Site 1017 — Oklahoma City, Oklahoma, United States
• Site 1007 — Philadelphia, Pennsylvania, United States
• Site 1022 — Dallas, Texas, United States
• Site 1005 — Brampton, Ontario, Canada
• Site 1025 — Kingston, Ontario, Canada

Full record on ClinicalTrials.gov

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