Clinical Trial Details

NCT ID: NCT02858453
Date Last Changed: September 6, 2017

Overview

Research Study Summary

A Phase 3 clinical study for patients with Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome or Chronic Interstitial Cystitis

Research Study Title

The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the Src Homology 2-containing Inositol-5'-Phosphatase 1 (SHIP1) Pathway in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Aquinox Pharmaceuticals (Canada) Inc.
Duration
17 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 80 Years

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 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

Site Locations (110)

Country State City Zip Facility and Contact
United States Alabama Homewood 35209 Site 9035
United States Arizona Tucson 85715 Site 9026
United States Arkansas Little Rock 72212 Site 9064
United States California Escondido 92025 Site 9060
United States California Los Angeles 90017 Site 9011
United States California Los Angeles 90027 Site 9021
United States California Los Angeles 90048 Site 9019
United States California Murrieta 92562 Site 9023
United States California Orange 92868 Site 9015
United States California Palo Alto 94304 Site 9039
United States California San Diego 92130 Site 9003
United States California Sherman Oaks 91411 Site 9046
United States California Whittier 90603 Site 9070
United States Connecticut Farmington 06032 Site 9004
United States Connecticut Middlebury 06762 Site 9029
United States Indiana Noblesville 46062 Site 9013
United States Iowa West Des Moines 50266 Site 9049
United States Louisiana Metairie 70001 Site 9054
United States Louisiana Shreveport 71106 Site 9007
United States Maryland Owings Mills 21114 Site 9038
United States Massachusetts Boston 02131 Site 9005
United States Massachusetts Watertown 02472 Site 9028
United States Michigan Grand Rapids 49546 Site 9034
United States Michigan Royal Oak 48073 Site 9020
United States Michigan Troy 48084 Site 9042
United States Nebraska Omaha 68114 Site 9072
United States New Jersey Cranford 07016 Site 9062
United States New Jersey Edison 08837 Site 9001
United States New Mexico Albuquerque 87109 Site 9025
United States New York Brooklyn 11215 Site 9016
United States New York Cheektowaga 14225 Site 9066
United States New York New Hyde Park 11042 Site 9037
United States New York The Bronx 10457 Site 9041
United States North Carolina Morehead City 28557 Site 9068
United States North Carolina Raleigh 27612 Site 9002
United States North Carolina Wilmington 28401 Site 9055
United States North Carolina Winston-Salem 27103 Site 9045
United States North Carolina Winston-Salem 27103 Site 9058
United States Ohio Cleveland 44109 Site 9048
United States Ohio Cleveland 44195 Site 9033
United States Ohio Gahanna 43230 Site 9047
United States Ohio Toledo 43614 Site 9051
United States Oklahoma Oklahoma City 73104 Site 9053
United States Oklahoma Oklahoma City 73120 Site 9071
United States Pennsylvania Bala-Cynwyd 19004 Site 9050
United States Pennsylvania Bryn Mawr 19010 Site 9031
United States Pennsylvania Newtown 18940 Site 9036
United States Pennsylvania Philadelphia 19140 Site 9032
United States South Carolina Greer 29650 Site 9040
United States Tennessee Franklin 37067 Site 9027
United States Texas Houston 77002 Site 9069
United States Texas Houston 77030 Site 9030
United States Texas Temple 76508 Site 9052
United States Virginia Richmond 23235 Site 9012
United States Washington Mountlake Terrace 98043 Site 9008
Belgium Gent 9000 Site 1102
Belgium Roeselare 8800 Site 1101
Canada British Columbia Kelowna V1W 4V5 Site 1013
Canada Ontario Brampton L6T 4S5 Site 1005
Canada Ontario Burlington L7N 3V2 Site 1006
Canada Ontario Kingston K7L 2V7 Site 1002
Canada Ontario Kitchener N2N 2B9 Site 1003
Canada Ontario Oakville I6J 3P1 Site 1015
Canada Ontario Toronto M3N 3M5 Site 1010
Canada Quebec Sherbrooke J1H 5N4 Site 1008
Czechia Hradec Kralove 50005 Site 2002
Czechia Jablonec nad Nisou 46601 Site 2006
Czechia Kolin 28002 Site 2003
Czechia Pilsen 30100 Site 2001
Czechia Prague 130 00 Site 2007
Czechia Praha 160 00 Site 2004
Czechia Uherske Hradiste 68668 Site 2005
Denmark Herlev 2730 Site 3002
Hungary Budapest 1204 Site 4004
Hungary Csongrad 6640 Site 4001
Hungary Sopron 9400 Site 4003
Latvia Daugavpils LV-5401 Site 5005
Latvia Jelgava LV-3001 Site 5001
Latvia Liepaja LV-3402 Site 5002
Latvia Riga LV-1002 Site 5003
Latvia Riga LV-1038 Site 5004
Poland Gdynia 81-148 Site 6009
Poland Piaseczno 05-500 Site 6005
Poland Poznan 60-586 Site 6001
Poland Poznań 61-512 Site 6007
Poland Siedlce 08-110 Site 6002
Poland Warsaw 03889 Site 6003
Poland Warszawa 00-714 Site 6008
Romania Braşov 500152 Site 7007
Romania Bucharest 022328 Site 7008
Romania Bucharest 14452 Site 7002
Romania Bucharest 21655 Site 7005
Romania Bucharest 41345 Site 7009
Romania Bucuresti 020125 Site 7010
Romania Bucuresti 50659 Site 7004
Romania Craiova 200349 Site 7006
Romania Craiova 200642 Site 7011
Romania Sibiu 550245 Site 7003
Spain Aravaca 28023 Site 1401
Spain Córdoba 14004 Site 1402
Spain Elche 03203 Site 1405
Spain Vic 08500 Site 1403
United Kingdom Devon Plymouth PL6 8DH Site 8008
United Kingdom South Yorkshire Sheffield S10 2JF Site 8001
United Kingdom Warwickshire Coventry CV2 2DX 8005
United Kingdom West Midlands Coventry CV2 2DX Site 8005
United Kingdom London W1G 8HU Site 8009
United Kingdom London W2 1NY Site 8004
United Kingdom Reading RG1 5AN Site 8002
United Kingdom Wakefield WF1 4DG Site 8003

Contact

Heidi Biagi
1 604 901 3028
E-mail:

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