Women and men needed to participate in a clinical research study of an oral investigational drug for interstitial cystitis/bladder pain syndrome (IC/BPS).
It is estimated that approximately 4% (25 million) of the adult population in the US and in Europe* may experience Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms.(1-3) If you or someone close to you has IC/BPS, you know how challenging it can be to live with its symptoms of ongoing bladder pain, urinary frequency (needing to go often), urgency (feeling a strong need to go), and/or pressure or discomfort in the bladder/pelvic area.
The Leadership 301 Trial is evaluating an investigational drug (AQX-1125) to see if it will reduce bladder pain and relieve other symptoms such as urinary frequency. The investigational drug is a new type of medication that may help reduce inflammation in the bladder. In an earlier study in women with IC/BPS, those who took the study drug every day for six weeks experienced reduced bladder pain and improved symptoms compared to those who took placebo.(4)
You may qualify if you:
- Are male or female between the ages of 18 and 80 years
- Have been diagnosed with IC/BPS for at least 3 months but less than 20 years
- Have consistently experienced moderate to severe bladder pain, urinary urgency, and/or urinary frequency
What will Happen During the Study
As a study participant, you will have regular contact with the study team who will monitor your health closely. There will be 13-14 visits during the study, which will last approximately 22 months. There will be a 12-week treatment period and a 52-week extension.
During the treatment period there will be a 1 in 3 chance you will receive placebo. After completing the treatment period, you will be randomized into an extension period where all patients receive active study drug. There will be a final follow-up visit 6 months after the last dose of study drug.
USA – Alabama, Arizona, California, Connecticut, Georgia, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin
Canada – British Columbia, Ontario, Quebec
Europe – Belgium, Czech Republic, Denmark, Hungary, Latvia, Netherlands, Poland, Romania, Spain, United Kingdom
Aquinox Pharmaceuticals (Canada) Inc.
Learn More Here –
To learn more about the Leadership 301 Trial and to find a participating study site close to you, visit http://www.leadership301.com/.
For additional study information: https://clinicaltrials.gov/ct2/show/NCT02858453
*European countries in this analysis include Germany, France, UK, Italy & Spain
- Leppilahti M, et al. J Urol. 2005;174(2):581-583;
- Berry SH, et al. J Urol. 2011;186(2):540-544;
- Suskind AM, et al. J Urol. 2013;189(1):141-145;
- Nickel JC, et al. J Urol. 2016;196(3):747-754.