About the Study
Evaluating an Investigational Foam to Manage IC/BPS Pain
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In an effort to develop a direct pain management option for bladder pain associated with IC/BPS, Ironwood is conducting a phase 2 clinical trial of a novel, rectally administered foam designed to target nerve receptors in the pelvic region.

When triggered, it is believed these receptors will release a compound that may lead to modifying the pain sensation caused by IC/BPS throughout the pelvic region.

The investigational drug takes an innovative approach to relieving bladder pain through the following chain of events:

The rectal route of administration was selected as a less irritating and easier way to administer the investigational drug in order to target its effects directly at the pelvic region. Through the chain of effects it triggers, the investigational drug may provide the bladder pain management patients seek to improve their quality of life.

Schematic of Study Design

The entire duration of the bladder pain study is approximately 21 weeks and is broken into four periods:

  • Screening Period: Spans up to 30 days.
  • Pretreatment Period: Occurs 14 to 21 days prior to the Treatment Period.
  • Treatment Period: Begins the day of the initial dose of the study drug and lasts for 12 weeks.
  • Two-Week Follow-Up Period: Two weeks after the last day of dosing, an End of Study Follow-Up Phone Call will be conducted.