Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome, Chronic Interstitial Cystitis

In brief

This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52 weeks.

Key facts

Study ID

NCT02858453

Run by

Aquinox Pharmaceuticals (Canada) Inc.

People needed

433

Starts

2016-07-01

Expected to finish

2020-02-01

Last updated by the study team

2018-03-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be male or female, ≥18 and ≤80 years of age who have had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 6 months
• Have had a clinical diagnosis, or history consistent with the diagnosis, of interstitial cystitis/bladder pain syndrome for >3 months but ≤20 years
• Must be capable of voiding independently
• Have undergone a cystoscopy within the last 36 months prior to Baseline
• Women of child bearing potential must have a negative pregnancy test, be non-lactating and agree to avoid pregnancy and use a highly effective method of contraception with one additional barrier method of contraception from screening until at least 28 days after the last dose of study drug has been taken
• Men must use a condom for sexual intercourse from screening until at least 90 days after last dose of study drug has been taken, unless they have been surgically sterilized (vasectomy)

You may not qualify if…

• Have had a urinary tract infection (UTI) including bacterial cystitis within the past 30 days
• Microscopic hematuria that has not been adequately evaluated as per local standard of care
• Have a history of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years
• History of previous procedure(s) (augmentation cystoplasty, cystectomy, cytolysis, botulinum toxin or bladder catheterization) that has significantly affected bladder function
• History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis
• Women: History of bladder tumors; uterine, cervical, vaginal or urethral cancer
• Men: History of prostate surgery (transurethral resection of the prostate [TURP], transurethral resection tumor [TURT], transurethral incision of the prostate [TUIP], transurethral needle ablation [TUNA] etc.), a history of prostate cancer or currently being treated for chronic bacterial prostatitis
• Major surgery within 3 months prior to Screening

Where it is running

• Site 9026 — Tucson, Arizona, United States
• Site 9064 — Little Rock, Arkansas, United States
• Site 9010 — Beverly Hills, California, United States
• Site 9060 — Escondido, California, United States
• Site 9011 — Los Angeles, California, United States
• Site 9021 — Los Angeles, California, United States
• Site 9019 — Los Angeles, California, United States
• Site 9023 — Murrieta, California, United States
• Site 9015 — Orange, California, United States
• Site 9039 — Palo Alto, California, United States
• Site 9003 — San Diego, California, United States
• Site 9046 — Sherman Oaks, California, United States
• Site 9070 — Whittier, California, United States
• Site 9004 — Farmington, Connecticut, United States
• Site 9029 — Middlebury, Connecticut, United States
• Site 9013 — Noblesville, Indiana, United States
• Site 9049 — West Des Moines, Iowa, United States
• Site 9054 — Metairie, Louisiana, United States
• Site 9007 — Shreveport, Louisiana, United States
• Site 9038 — Owings Mills, Maryland, United States
• Site 9005 — Boston, Massachusetts, United States
• Site 9028 — Watertown, Massachusetts, United States
• Site 9034 — Grand Rapids, Michigan, United States
• Site 9020 — Royal Oak, Michigan, United States
• Site 9035 — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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