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

Phase 2

Terminated

Conditions: Chronic Prostatitis
Chronic Pelvic Pain Syndrome

Interventions: Drug: AQX-1125 200 mg
Drug: Placebo

Registration Number: NCT03500159

Lead Sponsor: Aquinox Pharmaceuticals (Canada) Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 3

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AQX-1125	AQX-1125 200 mg	AQX-1125 200 mg
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)	12 Weeks	Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the maximum daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in NIH-CPSI	12 Weeks	Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) pain subscale and all domains total score
Change From Baseline to Week 12 in IIEF-EF	12 Weeks	Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in Male sexual health as measured using the International Index of Erectile Function Questionnaire, Erectile Function Domain (IIEF-EF)
Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),	12 Weeks	Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary)
Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic	12 Weeks	Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average and maximum pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded on paper-based questionnaire at clinic visits.
Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)	12 Weeks	Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in voiding frequency as recorded by electronic diary (eDiary)
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	16 Weeks	Change from Baseline at each clinic visit for AQX-1125 200 mg compared to placebo for; Mean of maximum daily pelvic pain score (eDiary), NIH-CPSI pain subscale and all domains total score, IIEF-EF, Mean of average daily pelvic pain scores (eDiary), average and maximum pelvic pain (Paper-based NRS in clinic), and 24-hour voiding frequency (eDiary)
Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA	12 Weeks	AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C	12 Weeks	AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Change Scale (PGI-C) at Week 12
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S	12 Weeks	AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Severity Scale (PGI-S) at Week 12
The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo	12 Weeks	Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement in maximum daily pelvic pain (mean) based on a standardized 11-point numeric rating scale (NRS) recorded by eDiary at Week 6 and 12
The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo	12 Weeks	Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement NIH-CPSI subscale at Week 6 and 12
Response to Treatment	12 Weeks	Response to treatment as defined by a decrease in maximum daily pelvic pain (eDiary) at Week 12 with a decrease or no change to concomitant analgesic medication use.
Discontinuation of Study Medication Due to Treatment Failure	12 Weeks
Frequency and Severity of Adverse Events (AEs)	12 Weeks

Trial Locations

Locations (27): Site 1016
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Los Angeles, California, United States
Site 1020
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Los Angeles, California, United States
Site 1001
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Cleveland, Ohio, United States
Site 1018
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Los Alamitos, California, United States
Site 1003
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Oakville, Ontario, Canada
Site 1026
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Homewood, Alabama, United States
Site 1004
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Tucson, Arizona, United States
Site 1028
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Laguna Hills, California, United States
Site 1015
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Springfield, Illinois, United States
Site 1014
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West Des Moines, Iowa, United States
Site 1027
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New Port Richey, Florida, United States
Site 1013
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Coeur d'Alene, Idaho, United States
Site 1023
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Jeffersonville, Indiana, United States
Site 1011
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Albuquerque, New Mexico, United States
Site 1002
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Royal Oak, Michigan, United States
Site 1012
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Shreveport, Louisiana, United States
Site 1009
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Lake Success, New York, United States
Site 1008
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Raleigh, North Carolina, United States
Site 1021
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Charlotte, North Carolina, United States
Site 1017
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Oklahoma City, Oklahoma, United States
Site 1022
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Dallas, Texas, United States
Site 1007
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Philadelphia, Pennsylvania, United States
Site 1025
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Kingston, Ontario, Canada
Site 1024
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Toronto, Ontario, Canada
Site 1019
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Wilmington, North Carolina, United States
Site 1005
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Brampton, Ontario, Canada
Site 1010
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Mobile, Alabama, United States