Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2013-06-30
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PK and Safety of SI-722 in IC/BPS
NCT04208087
Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis
NCT00380783
A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain
NCT01060254
A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)
NCT01613586
Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
NCT01559961
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AQX-1125
1 x AQX-1125 Capsule daily
AQX-1125
Synthetic SHIP1 activator
Placebo
1 x placebo capsule daily
Placebo
Double blind placebo capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AQX-1125
Synthetic SHIP1 activator
Placebo
Double blind placebo capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have had the diagnosis of interstitial cystitis for \> 6 months (pain for at least 12 months) but ≤15 years
* Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating Scale \[NRS\] pain scale in the 9 days prior to baseline
* Have undergone a cystoscopy and have documented visible signs of bladder bleeding, lesions or glomerulation within the last 36 months prior to baseline.
* Subjects if of child bearing potential, must agree to avoid pregnancy and use medically acceptable method of contraception from screening visit and throughout the study.
* Must be capable of voiding independently
Exclusion Criteria
* Have a body mass index \[BMI\] of \<18 kg/m2 or \>39 kg/m2
* Have had a urinary tract infection including bacterial cystitis within the past 30 days.
* Have greater than 1+ hematuria on dipstick test at screening from an unknown cause
* History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis) that has affected bladder function
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aquinox Pharmaceuticals (Canada) Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen B Shrewsbury, MD
Role: STUDY_DIRECTOR
Aquinox Pharmaceuticals (Canada) Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AQX/CMX site
Homewood, Alabama, United States
AQX/CMX site
Glendora, California, United States
AQX/CMX site
San Diego, California, United States
AQX/CMX site
Denver, Colorado, United States
AQX/CMX site
Farmington, Connecticut, United States
AQX/CMX site
Orlando, Florida, United States
AQX/CMX site
Shreveport, Louisiana, United States
AQX/CMX site
Troy, Michigan, United States
AQX/CMX site
Garden City, New York, United States
AQX/CMX Site
Winston-Salem, North Carolina, United States
AQX/CMX site
Toledo, Ohio, United States
AQX/CMX site
DeSoto, Texas, United States
AQX/CMX site
Calgary, Alberta, Canada
AQX/CMX site
Kelowna, British Columbia, Canada
AQX/CMX Site
Vancouver, British Columbia, Canada
AQX/CMX site
Victoria, British Columbia, Canada
AQX/CMX site
Halifax, Nova Scotia, Canada
AQX/CMX site
Barrie, Ontario, Canada
AQX/CMX site
Brampton, Ontario, Canada
AQX/CMX site
Brantford, Ontario, Canada
AQX/CMX site
Burlington, Ontario, Canada
AQX/CMX site
Kingston, Ontario, Canada
AQX/CMX site
Kitchener, Ontario, Canada
AQX/CMX site
Oakville, Ontario, Canada
AQX/CMX site
Toronto, Ontario, Canada
Dr Lesley Carr
Toronto, Ontario, Canada
AQX/CMX site
Granby, Quebec, Canada
AQX/CMX site
Montreal, Quebec, Canada
AQX/CMX site
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Related Links
Access external resources that provide additional context or updates about the study.
The Interstitial Cystitis Association (ICA) is the only nonprofit association dedicated solely to improving the quality of healthcare and lives of people living with interstitial cystitis (IC).
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AQX-1125-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.