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Clinical Trials/NCT03500159
NCT03500159TerminatedPhase 2

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

Aquinox Pharmaceuticals (Canada) Inc.27 sites in 2 countries3 target enrollmentStarted: April 18, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
3
Locations
27
Primary Endpoint
Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Arms & Interventions

AQX-1125

Experimental

AQX-1125 200 mg

Intervention: AQX-1125 200 mg (Drug)

Placebo

Placebo Comparator

Matching placebo

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)

Time Frame: 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 Outcomes

  • Change From Baseline to Week 12 in NIH-CPSI(12 Weeks)
  • Change From Baseline to Week 12 in IIEF-EF(12 Weeks)
  • Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),(12 Weeks)
  • Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic(12 Weeks)
  • Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)(12 Weeks)
  • 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)
  • Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA(12 Weeks)
  • Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C(12 Weeks)
  • Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S(12 Weeks)
  • The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo(12 Weeks)
  • The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo(12 Weeks)
  • Response to Treatment(12 Weeks)
  • Discontinuation of Study Medication Due to Treatment Failure(12 Weeks)
  • Frequency and Severity of Adverse Events (AEs)(12 Weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (27)

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