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

NCT03500159 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AQX-1125-205
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 27

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.

Conditions

Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

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

  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)

  12 Weeks

Secondary Outcomes (14)

• 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

Study Arms (2)

AQX-1125

EXPERIMENTAL

AQX-1125 200 mg

Drug: AQX-1125 200 mg

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

AQX-1125 200 mg DRUG

Synthetic SHIP1 activator

Also known as: Rosiptor

AQX-1125

Placebo DRUG

Appearance and weight matched tablets without the active product ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Aquinox Pharmaceuticals (Canada) Inc.: lead

Study Sites (27)

Site 1026

Homewood, Alabama, 35209, United States

Location

Site 1010

Mobile, Alabama, 36608, United States

Location

Site 1004

Tucson, Arizona, 85710, United States

Location

Site 1028

Laguna Hills, California, 92653, United States

Location

Site 1018

Los Alamitos, California, 90720, United States

Location

Site 1016

Los Angeles, California, 90048, United States

Location

Site 1020

Los Angeles, California, 90048, United States

Location

Site 1027

New Port Richey, Florida, 34653, United States

Location

Site 1013

Coeur d'Alene, Idaho, 83814, United States

Location

Site 1015

Springfield, Illinois, 62769, United States

Location

Site 1023

Jeffersonville, Indiana, 47130, United States

Location

Site 1014

West Des Moines, Iowa, 50266, United States

Location

Site 1012

Shreveport, Louisiana, 71106, United States

Location

Site 1002

Royal Oak, Michigan, 48072, United States

Location

Site 1011

Albuquerque, New Mexico, 87109, United States

Location

Site 1009

Lake Success, New York, 11042, United States

Location

Site 1021

Charlotte, North Carolina, 28207, United States

Location

Site 1008

Raleigh, North Carolina, 27612, United States

Location

Site 1019

Wilmington, North Carolina, 28401, United States

Location

Site 1001

Cleveland, Ohio, 44195, United States

Location

Site 1017

Oklahoma City, Oklahoma, 73120, United States

Location

Site 1007

Philadelphia, Pennsylvania, 19140, United States

Location

Site 1022

Dallas, Texas, 75231, United States

Location

Site 1005

Brampton, Ontario, L6T 4S5, Canada

Location

Site 1025

Kingston, Ontario, K7L 3J7, Canada

Location

Site 1003

Oakville, Ontario, L6H 3P1, Canada

Location

Site 1024

Toronto, Ontario, M6A 3B5, Canada

Location

MeSH Terms

Interventions

4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol

Results Point of Contact

• Title: Clinical
• Organization: Aquinox Pharmaceuticals (Canada) Inc.

clinical@aqxpharma.com

604-629-9223

Study Officials

• Daniel Shoskes, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 17, 2018
• Study Start: April 18, 2018
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: January 9, 2019
• Results First Posted: January 9, 2019

Record last verified: 2018-12

Locations

US (23); CA (4)