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Aquinox Clinical Trial Seeks Men & Women With IC/BPS in 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).

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 SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by a 40-Week Extension Period

Sponsor

Aquinox Pharmaceuticals (Canada) Inc.

Purpose

The purpose of the LEADERSHIP 301 Trial is to learn if an investigational drug, AQX-1125, may reduce the bladder pain of interstitial cystitis/bladder pain syndrome (IC/BPS) and relieve other symptoms such as urinary urgency and frequency. The study drug is a new type of medication that may help reduce inflammation in the bladder.

An earlier clinical study in women with IC/BPS showed that the women who took the study drug every day for 6 weeks experienced reduced bladder pain and improved symptoms compared to those who took placebo.

Eligibility

You may qualify if you:

  • Are between the ages of 18 and 80
  • Have been diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS) for at least 3 months
  • 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 our study team who will monitor your health closely. There will be 11-12 visits during the study, which will last 16 months.  There will be a 12-week treatment period and a 40-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.

Contact to learn more

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

By | 2017-03-16T15:20:02+00:00 March 16th, 2017|Clinical Trials, Research|Comments Off on Aquinox Clinical Trial Seeks Men & Women With IC/BPS in 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.