Clinical Trial 55310

Jeffersonville, IN 47130


<b>Interstitial Cystitis and Bladder Pain Syndrome - Multiple Locations in the US</b>

IC/BPS Study: An investigational foam that may relieve bladder pain associated with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)

The IC/BPS Clinical Study is a clinical research study for people who experience bladder pain associated with interstitial cystitis and bladder pain syndrome (IC/BPS). The study is evaluating a non-opioid, investigational drug administered directly to the pelvic region as a foam, which may help relieve bladder pain associated with IC/BPS and could potentially improve quality of life.

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 from chronic bladder pain associated with filling the bladder for six months or more
  • 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.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.