Global IC/BPS Clinical Trial Seeks Men & Women With IC/BPS (USA, Canada, Europe) -  Interstitial Cystitis Network 

Home/Research/Clinical Trials/Global IC/BPS Clinical Trial Seeks Men & Women With IC/BPS (USA, Canada, Europe)

Global IC/BPS Clinical Trial Seeks Men & Women With IC/BPS (USA, Canada, Europe)

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.

Purpose

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)

Eligibility

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.

Study Locations

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

Sponsor

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

 

References:

  1. Leppilahti M, et al. J Urol. 2005;174(2):581-583;
  2. Berry SH, et al. J Urol. 2011;186(2):540-544;
  3. Suskind AM, et al. J Urol. 2013;189(1):141-145;
  4. Nickel JC, et al. J Urol. 2016;196(3):747-754.

 

By | 2017-08-15T13:23:14+00:00 March 16th, 2017|Clinical Trials, Research|Comments Off on Global IC/BPS Clinical Trial Seeks Men & Women With IC/BPS (USA, Canada, Europe)

About the Author:

My Google Profile+ Jill Heidi Osborne is the president and founder of the Interstitial Cystitis Network, a health education company dedicated to interstitial cystitis, bladder pain syndrome and other pelvic pain disorders.

As the editor and lead author of the ICN and the IC Optimist magazine, Jill is proud of the academic recognition that her website has achieved. The University of London rated the ICN as the top IC website for accuracy, credibility, readability and quality. (Int Urogynecol J – April 2013). Harvard Medical School rated both Medscape and the ICN as the top two websites dedicated to IC. (Urology – Sept 11). Jill currently serves on the Congressionally Directed Medical Research Panel (US Army) where she collaborates with researchers to evaluate new IC research studies for possible funding. Jill has conducted and/or collaborates on a variety of IC research studies on new therapeutics, pain care, sexuality, the use of medical marijuana, menopause and the cost of treatments, shining a light on issues that influence patient quality of life.

An IC support group leader and national spokesperson for the past 20 years, she has represented the IC community on radio, TV shows, at medical conferences. She has written hundreds of articles on IC and its related conditions.

With a Bachelors Degree in Pharmacology and a Masters in Psychology, Jill was named Presidential Management Intern (aka Fellowship) while in graduate school. (She was unable to earn her PhD due to the onset of her IC.) She spends the majority of her time providing WELLNESS COACHING for patients in need and developing new, internet based educational and support tools for IC patients, including the “Living with IC” video series currently on YouTube and the ICN Food List smartphone app! Jill was diagnosed with IC at the age of 32 but first showed symptoms at the age of 12.