Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
- Conditions
- Chronic Interstitial CystitisInterstitial CystitisBladder Pain SyndromePainful Bladder Syndrome
- Interventions
- Registration Number
- NCT02858453
- Lead Sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Brief 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.
- Detailed Description
This multi-center Phase 3 trial includes a randomized, double-blind, placebo-controlled, parallel-group, treatment phase to evaluate the efficacy and safety of 2 doses of oral AQX-1125 in up to 600 subjects with interstitial cystitis/bladder pain syndrome.
The primary objective of this study is to evaluate the effect of 12 weeks of treatment of AQX-1125 (100 mg or 200 mg) administered once daily compared to placebo on the change from Baseline to Week 12 in maximum daily bladder pain using a standardized 11-point numerical rating scale pain score recorded daily by electronic diary (e-diary).
The 12-week Treatment Period is followed by an Extension Period of 52 weeks. Randomization and start of dosing occurs at Baseline and is followed by visits at Week 6 and Week 12. At the end of Week 12, subjects will be randomized into the 52-week Extension Period. Subjects on active treatment during the Treatment Period will continue on that same dose for the Extension Period, while subjects receiving placebo during the Treatment Period will be randomized to one of the active doses of 100 mg or 200 mg AQX-1125 for 52 weeks.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 433
- 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 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AQX-1125 100 mg AQX-1125 100 mg 2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period Placebo Placebo 2 placebo tablets, by mouth, once per day for 12 weeks; followed by randomization to 100 mg or 200 mg AQX-1125 for a 52-week Extension Period AQX-1125 200 mg AQX-1125 200 mg 2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
- Primary Outcome Measures
Name Time Method Change from Baseline in Maximum Daily Bladder Pain Score Baseline to 12 weeks Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in the maximum daily bladder pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (e-diary)
- Secondary Outcome Measures
Name Time Method Change from Baseline in Voiding Frequency Measured Over a 24 hr Period Baseline to 12 weeks Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in voiding frequency measured over a 24-hour period
Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score Baseline to 12 weeks Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Bladder Pain/Interstitial Cystitis Symptom Score
Change from Baseline Interstitial Cystitis Symptom Index Score Baseline to 12 weeks Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in Interstitial Cystitis Symptom Index Score
Change from Baseline in Subject's Global Response Assessment Baseline to 12 weeks Change from Baseline for AQX-1125 100 mg or 200 mg compared to placebo in subject's Global Response Assessment
Trial Locations
- Locations (119)
Site 1016
🇨🇦Sherbrooke, Quebec, Canada
Site 9005
🇺🇸Boston, Massachusetts, United States
Site 1401
🇪🇸Aravaca, Spain
Site 9039
🇺🇸Palo Alto, California, United States
Site 9041
🇺🇸Bronx, New York, United States
Site 9035
🇺🇸Homewood, Alabama, United States
Site 9003
🇺🇸San Diego, California, United States
Site 9060
🇺🇸Escondido, California, United States
Site 9046
🇺🇸Sherman Oaks, California, United States
Site 9071
🇺🇸Oklahoma City, Oklahoma, United States
Site 9011
🇺🇸Los Angeles, California, United States
Site 9019
🇺🇸Los Angeles, California, United States
Site 9023
🇺🇸Murrieta, California, United States
Site 9013
🇺🇸Noblesville, Indiana, United States
Site 9033
🇺🇸Cleveland, Ohio, United States
Site 9031
🇺🇸Bryn Mawr, Pennsylvania, United States
Site 9052
🇺🇸Temple, Texas, United States
Site 9037
🇺🇸New Hyde Park, New York, United States
Site 8007
🇬🇧Wolverhampton, West Midlands, United Kingdom
Site 9034
🇺🇸Grand Rapids, Michigan, United States
Site 9008
🇺🇸Mountlake Terrace, Washington, United States
Site 8004
🇬🇧London, United Kingdom
Site 1101
🇧🇪Roeselare, Belgium
Site 1006
🇨🇦Burlington, Ontario, Canada
Site 3002
🇩🇰Herlev, Denmark
Site 9068
🇺🇸Morehead City, North Carolina, United States
Site 2007
🇨🇿Prague, Czechia
Site 4001
🇭🇺Csongrad, Hungary
Site 4003
🇭🇺Sopron, Hungary
Site 6009
🇵🇱Gdynia, Poland
Site 7006
🇷🇴Craiova, Romania
Site 1002
🇨🇦Kingston, Ontario, Canada
Site 2001
🇨🇿Pilsen, Czechia
Site 9002
🇺🇸Raleigh, North Carolina, United States
Site 9036
🇺🇸Newtown, Pennsylvania, United States
Site 8009
🇬🇧London, United Kingdom
Site 2006
🇨🇿Jablonec nad Nisou, Czechia
Site 1013
🇨🇦Kelowna, British Columbia, Canada
Site 1005
🇨🇦Brampton, Ontario, Canada
Site 1015
🇨🇦Oakville, Ontario, Canada
Site 2002
🇨🇿Hradec Kralove, Czechia
Site 1402
🇪🇸Córdoba, Spain
Site 2004
🇨🇿Praha, Czechia
Site 1405
🇪🇸Elche, Spain
Site 8001
🇬🇧Sheffield, South Yorkshire, United Kingdom
Site 8002
🇬🇧Reading, United Kingdom
Site 2003
🇨🇿Kolin, Czechia
Site 4004
🇭🇺Budapest, Hungary
Site 8008
🇬🇧Plymouth, Devon, United Kingdom
Site 1403
🇪🇸Vic, Spain
Site 9069
🇺🇸Houston, Texas, United States
Site 9030
🇺🇸Houston, Texas, United States
Site 5005
🇱🇻Daugavpils, Latvia
Site 5001
🇱🇻Jelgava, Latvia
Site 1302
🇳🇱Den Haag, Netherlands
Site 6008
🇵🇱Warszawa, Poland
Site 7001
🇷🇴Târgu-Mureş, Romania
Site 9015
🇺🇸Orange, California, United States
Site 9045
🇺🇸Winston-Salem, North Carolina, United States
Site 9048
🇺🇸Cleveland, Ohio, United States
Site 9047
🇺🇸Gahanna, Ohio, United States
Site 9051
🇺🇸Toledo, Ohio, United States
Site 9050
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Site 9032
🇺🇸Philadelphia, Pennsylvania, United States
Site 9021
🇺🇸Los Angeles, California, United States
Site 9010
🇺🇸Beverly Hills, California, United States
Site 9064
🇺🇸Little Rock, Arkansas, United States
Site 9016
🇺🇸Brooklyn, New York, United States
Site 9042
🇺🇸Troy, Michigan, United States
Site 9025
🇺🇸Albuquerque, New Mexico, United States
Site 9066
🇺🇸Cheektowaga, New York, United States
Site 9055
🇺🇸Wilmington, North Carolina, United States
Site 9053
🇺🇸Oklahoma City, Oklahoma, United States
Site 1103
🇧🇪Edegem, Belgium
Site 9027
🇺🇸Franklin, Tennessee, United States
Site 1003
🇨🇦Kitchener, Ontario, Canada
Site 1301
🇳🇱Rotterdam, South Holland, Netherlands
Site 6004
🇵🇱Gdynia, Poland
Site 6005
🇵🇱Piaseczno, Poland
Site 8003
🇬🇧Wakefield, United Kingdom
Site 2005
🇨🇿Uherske Hradiste, Czechia
Site 9026
🇺🇸Tucson, Arizona, United States
Site 9012
🇺🇸Richmond, Virginia, United States
Site 1010
🇨🇦Toronto, Ontario, Canada
Site 1008
🇨🇦Sherbrooke, Quebec, Canada
Site 9004
🇺🇸Farmington, Connecticut, United States
Site 1102
🇧🇪Gent, Belgium
Site 1017
🇨🇦Québec, Quebec, Canada
Site 5002
🇱🇻Liepaja, Latvia
Site 5003
🇱🇻Riga, Latvia
Site 5004
🇱🇻Riga, Latvia
Site 6011
🇵🇱Bydgoszcz, Poland
Site 6001
🇵🇱Poznan, Poland
Site 6007
🇵🇱Poznań, Poland
Site 6002
🇵🇱Siedlce, Poland
Site 6003
🇵🇱Warsaw, Poland
Site 7007
🇷🇴Braşov, Romania
Site 7005
🇷🇴Bucharest, Romania
Site 7009
🇷🇴Bucharest, Romania
Site 7010
🇷🇴Bucuresti, Romania
Site 7004
🇷🇴Bucuresti, Romania
Site 7003
🇷🇴Sibiu, Romania
Site 9020
🇺🇸Royal Oak, Michigan, United States
Site 9072
🇺🇸Omaha, Nebraska, United States
Site 9029
🇺🇸Middlebury, Connecticut, United States
Site 9054
🇺🇸Metairie, Louisiana, United States
Site 9028
🇺🇸Watertown, Massachusetts, United States
Site 9001
🇺🇸Edison, New Jersey, United States
Site 7008
🇷🇴Bucharest, Romania
Site 7002
🇷🇴Bucharest, Romania
Site 7011
🇷🇴Craiova, Romania
Site 9007
🇺🇸Shreveport, Louisiana, United States
Site 9062
🇺🇸Cranford, New Jersey, United States
Site 9040
🇺🇸Greer, South Carolina, United States
8005
🇬🇧Coventry, Warwickshire, United Kingdom
Site 9058
🇺🇸Winston-Salem, North Carolina, United States
Site 9070
🇺🇸Whittier, California, United States
Site 9049
🇺🇸West Des Moines, Iowa, United States
Site 9038
🇺🇸Owings Mills, Maryland, United States