Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
NCT ID: NCT03500159
Last Updated: 2019-01-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2018-04-18
2018-07-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AQX-1125
AQX-1125 200 mg
AQX-1125 200 mg
Synthetic SHIP1 activator
Placebo
Matching placebo
Placebo
Appearance and weight matched tablets without the active product ingredient
Interventions
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AQX-1125 200 mg
Synthetic SHIP1 activator
Placebo
Appearance and weight matched tablets without the active product ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
MALE
No
Sponsors
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Aquinox Pharmaceuticals (Canada) Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Shoskes, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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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
Site 1003
Oakville, Ontario, Canada
Site 1024
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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AQX-1125-205
Identifier Type: -
Identifier Source: org_study_id
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