for people ages 18-75 (full criteria)
at Orange, California and other locations
study started
completion around



The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.

Official Title

A Phase 2 Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate the Efficacy, Safety, and Tolerability of 2 Dose Levels of IW-3300 Administered Rectally for 12 Weeks to Treat Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome


This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 weeks.


Interstitial Cystitis, Bladder Pain Syndrome, Cystitis, Syndrome, Somatoform Disorders, IW-3300 rectal foam


You can join if…

Open to people ages 18-75

  • Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS
  • Chronic bladder pain associated with filling the bladder over the past 6 months
  • Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period
  • Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency
  • Body mass index (BMI) ≤40 kg/m2
  • Willing to use a rectally administered product once daily for 12 weeks

You CAN'T join if...

  • Male subject has history of bacterial prostatitis or benign prostatic hyperplasia with active symptoms that are difficult to distinguish from IC/BPS
  • Has a condition that can be a contraindication to using a rectal foam
  • Has cancer under active treatment or a history of uterine, cervical, pelvic, colorectal, ovarian, or vaginal cancer
  • Has a history of benign or malignant bladder tumors
  • Has an active urinary tract infection or had ≥2 UTIs within the past 90 days
  • Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years
  • Has a malabsorption syndrome
  • Had surgery in the pelvic or abdominal region within the past 90 days or is planning pelvic or abdominal region surgical procedures before the end of the study
  • Has received a cystoscopy with or without hydrodistension for diagnostic purposes (ie, not for pain relief) within the past 30 days or a cystoscopy with therapeutic hydrodistension (ie, for pain relief) within the past 90 days or is planning a cystoscopy for any reason before the end of the study
  • Has history of pelvic irradiation or radiation cystitis, or drug-induced cystitis.
  • Has a recent history of drug or alcohol abuse


  • UCI Health accepting new patients
    Orange California 92868 United States
  • Tri Valley Urology Medical Group accepting new patients
    Murrieta California 92562 United States


accepting new patients
Start Date
Completion Date
Ironwood Pharmaceuticals, Inc.
Phase 2 Interstitial Cystitis Research Study
Study Type
Expecting 300 study participants
Last Updated