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

NCT02858453 | Unknown Phase 3

• 1 other identifier: AQX-1125-301
• Study Type: interventional
• Target: 433
• Locations: 12 countries
• Sites: 120

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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome; Painful Bladder Syndrome; Chronic Interstitial Cystitis

Keywords

Interstitial cystitis; Bladder pain syndrome; Painful bladder syndrome; Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS); AQX-1125; SHIP1; Chronic interstitial cystitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Maximum Daily Bladder Pain Score

  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)

  Baseline to 12 weeks

Secondary Outcomes (4)

• Change from Baseline in Voiding Frequency Measured Over a 24 hr Period

  Baseline to 12 weeks

• Change from Baseline Interstitial Cystitis Symptom Index Score

  Baseline to 12 weeks

• Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score

  Baseline to 12 weeks

• Change from Baseline in Subject's Global Response Assessment

  Baseline to 12 weeks

Other Outcomes (1)

• Frequency and Severity of Adverse Events

  Baseline to 12-weeks; during 52-week EP and baseline to 64-weeks, with a 4-week post-dose, and 6 month post-dose (ocular only), follow-up

Study Arms (3)

AQX-1125 100 mg

EXPERIMENTAL

2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period

Drug: AQX-1125 100 mg

AQX-1125 200 mg

EXPERIMENTAL

2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period

Drug: AQX-1125 200 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AQX-1125 100 mg DRUG

Synthetic SHIP1 activator

AQX-1125 100 mg

AQX-1125 200 mg DRUG

Synthetic SHIP1 activator

AQX-1125 200 mg

Placebo DRUG

Appearance and weight matched placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Aquinox Pharmaceuticals (Canada) Inc.: lead

Study Sites (120)

Site 9035

Homewood, Alabama, 35209, United States

Location

Site 9026

Tucson, Arizona, 85715, United States

Location

Site 9064

Little Rock, Arkansas, 72212, United States

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Site 9010

Beverly Hills, California, 90211, United States

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Site 9060

Escondido, California, 92025, United States

Location

Site 9011

Los Angeles, California, 90017, United States

Location

Site 9021

Los Angeles, California, 90027, United States

Location

Site 9019

Los Angeles, California, 90048, United States

Location

Site 9023

Murrieta, California, 92562, United States

Location

Site 9015

Orange, California, 92868, United States

Location

Site 9039

Palo Alto, California, 94304, United States

Location

Site 9003

San Diego, California, 92130, United States

Location

Site 9046

Sherman Oaks, California, 91411, United States

Location

Site 9070

Whittier, California, 90603, United States

Location

Site 9004

Farmington, Connecticut, 06032, United States

Location

Site 9029

Middlebury, Connecticut, 06762, United States

Location

Site 9013

Noblesville, Indiana, 46062, United States

Location

Site 9049

West Des Moines, Iowa, 50266, United States

Location

Site 9054

Metairie, Louisiana, 70001, United States

Location

Site 9007

Shreveport, Louisiana, 71106, United States

Location

Site 9038

Owings Mills, Maryland, 21114, United States

Location

Site 9005

Boston, Massachusetts, 02131, United States

Location

Site 9028

Watertown, Massachusetts, 02472, United States

Location

Site 9034

Grand Rapids, Michigan, 49546, United States

Location

Site 9020

Royal Oak, Michigan, 48073, United States

Location

Site 9042

Troy, Michigan, 48084, United States

Location

Site 9072

Omaha, Nebraska, 68114, United States

Location

Site 9062

Cranford, New Jersey, 07016, United States

Location

Site 9001

Edison, New Jersey, 08837, United States

Location

Site 9025

Albuquerque, New Mexico, 87109, United States

Location

Site 9016

Brooklyn, New York, 11215, United States

Location

Site 9066

Cheektowaga, New York, 14225, United States

Location

Site 9037

New Hyde Park, New York, 11042, United States

Location

Site 9041

The Bronx, New York, 10457, United States

Location

Site 9068

Morehead City, North Carolina, 28557, United States

Location

Site 9002

Raleigh, North Carolina, 27612, United States

Location

Site 9055

Wilmington, North Carolina, 28401, United States

Location

Site 9045

Winston-Salem, North Carolina, 27103, United States

Location

Site 9058

Winston-Salem, North Carolina, 27103, United States

Location

Site 9048

Cleveland, Ohio, 44109, United States

Location

Site 9033

Cleveland, Ohio, 44195, United States

Location

Site 9047

Gahanna, Ohio, 43230, United States

Location

Site 9051

Toledo, Ohio, 43614, United States

Location

Site 9053

Oklahoma City, Oklahoma, 73104, United States

Location

Site 9071

Oklahoma City, Oklahoma, 73120, United States

Location

Site 9050

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Site 9031

Bryn Mawr, Pennsylvania, 19010, United States

Location

Site 9036

Newtown, Pennsylvania, 18940, United States

Location

Site 9032

Philadelphia, Pennsylvania, 19140, United States

Location

Site 9040

Greer, South Carolina, 29650, United States

Location

Site 9027

Franklin, Tennessee, 37067, United States

Location

Site 9069

Houston, Texas, 77002, United States

Location

Site 9030

Houston, Texas, 77030, United States

Location

Site 9052

Temple, Texas, 76508, United States

Location

Site 9012

Richmond, Virginia, 23235, United States

Location

Site 9008

Mountlake Terrace, Washington, 98043, United States

Location

Site 1103

Edegem, 2650, Belgium

Location

Site 1102

Ghent, 9000, Belgium

Location

Site 1101

Roeselare, 8800, Belgium

Location

Site 1013

Kelowna, British Columbia, V1W 4V5, Canada

Location

Site 1005

Brampton, Ontario, L6T 4S5, Canada

Location

Site 1006

Burlington, Ontario, L7N 3V2, Canada

Location

Site 1002

Kingston, Ontario, K7L 2V7, Canada

Location

Site 1003

Kitchener, Ontario, N2N 2B9, Canada

Location

Site 1015

Oakville, Ontario, I6J 3P1, Canada

Location

Site 1010

Toronto, Ontario, M3N 3M5, Canada

Location

Site 1017

Québec, Quebec, G1N 4V3, Canada

Location

Site 1017

Québec, Quebec, G1S2L6, Canada

Location

Site 1016

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Site 1008

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Site 2002

Hradec Králové, 50005, Czechia

Location

Site 2006

Jablonec nad Nisou, 46601, Czechia

Location

Site 2003

Kolín, 28002, Czechia

Location

Site 2001

Pilsen, 30100, Czechia

Location

Site 2007

Prague, 130 00, Czechia

Location

Site 2004

Prague, 160 00, Czechia

Location

Site 2005

Uherské Hradiště, 68668, Czechia

Location

Site 3002

Herlev, 2730, Denmark

Location

Site 4004

Budapest, 1204, Hungary

Location

Site 4001

Csongrád, 6640, Hungary

Location

Site 4003

Sopron, 9400, Hungary

Location

Site 5005

Daugavpils, LV-5401, Latvia

Location

Site 5001

Jelgava, LV-3001, Latvia

Location

Site 5002

Liepāja, LV-3402, Latvia

Location

Site 5003

Riga, LV-1002, Latvia

Location

Site 5004

Riga, LV-1038, Latvia

Location

Site 1301

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Site 1302

The Hague, 2594 AB, Netherlands

Location

Site 6011

Bydgoszcz, 85-312, Poland

Location

Site 6009

Gdynia, 81-148, Poland

Location

Site 6004

Gdynia, 81-366, Poland

Location

Site 6005

Piaseczno, 05-500, Poland

Location

Site 6001

Poznan, 60-586, Poland

Location

Site 6007

Poznan, 61-512, Poland

Location

Site 6002

Siedlce, 08-110, Poland

Location

Site 6008

Warsaw, 00-714, Poland

Location

Site 6003

Warsaw, 03889, Poland

Location

Site 7007

Brasov, 500152, Romania

Location

Site 7010

Bucharest, 020125, Romania

Location

Site 7008

Bucharest, 022328, Romania

Location

Site 7002

Bucharest, 14452, Romania

Location

Site 7005

Bucharest, 21655, Romania

Location

Site 7009

Bucharest, 41345, Romania

Location

Site 7004

Bucharest, 50659, Romania

Location

Site 7006

Craiova, 200349, Romania

Location

Site 7011

Craiova, 200642, Romania

Location

Site 7003

Sibiu, 550245, Romania

Location

Site 7001

Târgu Mureş, 540353, Romania

Location

Site 1401

Aravaca, 28023, Spain

Location

Site 1402

Córdoba, 14004, Spain

Location

Site 1405

Elche, 03203, Spain

Location

Site 1403

Vic, 08500, Spain

Location

Site 8008

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Site 8001

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

8005

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Site 8007

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Site 8009

London, W1G 8HU, United Kingdom

Location

Site 8004

London, W2 1NY, United Kingdom

Location

Site 8002

Reading, RG1 5AN, United Kingdom

Location

Site 8003

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Robert Moldwin, MD

  Hofstra Northwell School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: August 8, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2020
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

NL (2); BE (3); RO (11); CA (11); ES (4); DK (1); PL (9); GB (8); HU (3); US (56); LA (5); CZ (7)