Clinical trial NCT03500159: Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Lead sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change From Baseline to Week 12 in NIH-CPSI
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in IIEF-EF
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic
timeFrame: 12 Weeks
measure: Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)
timeFrame: 12 Weeks
measure: Time Course of Effects From Baseline Through to Week 16: AQX-1125 200 mg Compared to Placebo for Each of the Pain and Symptom Scale Endpoints
timeFrame: 16 Weeks
measure: Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA
timeFrame: 12 Weeks
measure: Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C
timeFrame: 12 Weeks
measure: Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S
timeFrame: 12 Weeks
measure: The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo
timeFrame: 12 Weeks
measure: The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo
timeFrame: 12 Weeks
measure: Response to Treatment
timeFrame: 12 Weeks
measure: Discontinuation of Study Medication Due to Treatment Failure
timeFrame: 12 Weeks
measure: Frequency and Severity of Adverse Events (AEs)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Site 1026
state: Alabama
city: Mobile
country: United States
facility: Site 1010
state: Alabama
city: Tucson
country: United States
facility: Site 1004
state: Arizona
city: Laguna Hills
country: United States
facility: Site 1028
state: California
city: Los Alamitos
country: United States
facility: Site 1018
state: California
city: Los Angeles
country: United States
facility: Site 1016
state: California
city: Los Angeles
country: United States
facility: Site 1020
state: California
city: New Port Richey
country: United States
facility: Site 1027
state: Florida
city: Coeur d'Alene
country: United States
facility: Site 1013
state: Idaho
city: Springfield
country: United States
facility: Site 1015
state: Illinois
city: Jeffersonville
country: United States
facility: Site 1023
state: Indiana
city: West Des Moines
country: United States
facility: Site 1014
state: Iowa
city: Shreveport
country: United States
facility: Site 1012
state: Louisiana
city: Royal Oak
country: United States
facility: Site 1002
state: Michigan
city: Albuquerque
country: United States
facility: Site 1011
state: New Mexico
city: Lake Success
country: United States
facility: Site 1009
state: New York
city: Charlotte
country: United States
facility: Site 1021
state: North Carolina
city: Raleigh
country: United States
facility: Site 1008
state: North Carolina
city: Wilmington
country: United States
facility: Site 1019
state: North Carolina
city: Cleveland
country: United States
facility: Site 1001
state: Ohio
city: Oklahoma City
country: United States
facility: Site 1017
state: Oklahoma
city: Philadelphia
country: United States
facility: Site 1007
state: Pennsylvania
city: Dallas
country: United States
facility: Site 1022
state: Texas
city: Brampton
country: Canada
facility: Site 1005
state: Ontario
city: Kingston
country: Canada
facility: Site 1025
state: Ontario
city: Oakville
country: Canada
facility: Site 1003
state: Ontario
city: Toronto
country: Canada
facility: Site 1024
state: Ontario
Study officials:
affiliation: The Cleveland Clinic
name: Daniel Shoskes, MD
role: PRINCIPAL_INVESTIGATOR
References: