Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain … (NCT02858453) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
United States433 participantsStarted 2016-07
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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)
Exclusion Criteria
* 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 cys…
What they're measuring
1
Change from Baseline in Maximum Daily Bladder Pain Score