IC/BPS Clinical Study

Now enrolling patients with bladder pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS)

IC/BPS Clinical Study: Now enrolling patients with bladder pain associated with IC/BPS

Working toward a life less interrupted for people with IC/BPS.

Living with interstitial cystitis and bladder pain syndrome (IC/BPS) can be debilitating, but Ironwood is sponsoring a clinical research study of a new potential treatment that could offer relief. The IC/BPS Clinical Study will evaluate an investigational, foam-based drug designed to inhibit pain receptors in the colon, which may modify pain in the bladder.

Many of the 4 to 12 million people in the U.S. with IC/BPS may be interested in a new option for pain management as they have been unable to find relief from the discomfort and life interruption associated with the disease. This is why we’re conducting the IC/BPS Clinical Study.

What is IC/BPS?

IC/BPS is a chronic condition with symptoms of increased urinary urgency and frequency, nighttime urination, bladder pressure and severe pelvic pain. Pain and symptoms experienced due to IC/BPS can make daily life difficult and painful and may be so severe that they can negatively impact a person’s quality of life.

In an effort to develop a safe, dedicated, potential pain management option to relieve IC/BPS pain, Ironwood is conducting a phase 2 clinical trial of a novel, rectally administered foam. The study drug is designed to utilize the shared nerve pathways between the colon and bladder to modify pain signals in the colon, which might also relieve bladder pain associated with IC/BPS.

IC/BPS Clinical Study at a Glance

  • Participants: 300
  • Duration: Up to 21 weeks (including Screening Period)
  • Administration: Rectal
  • Study Groups: Three groups (two groups receiving doses of the investigational drug and one group receiving placebo)

To participate in this study, you must meet these criteria*:

  • Adult between the ages of 18 and 70
  • Suffering for six months or more from chronic bladder pain associated with filling the bladder
  • Experiencing at least one of the following urinary symptoms related to IC/BPS for six months or more:
    • Nighttime urination, two or more times per night
    • Frequent urination during the daytime, more than eight times per day
    • Urination urgency

*Other criteria will apply.

While participating in the study, you’ll receive one of two doses of the investigational drug or a matching placebo, study-related care and monitoring of your IC/BPS symptoms and compensation for travel and expenses related to study participation, if needed.

To learn more and find out if you may be eligible, please visit icbpsclinicalstudy.com