A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Interstitial Cystitis, Bladder Pain Syndrome

In brief

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.

Key facts

Study ID

NCT05740007

Run by

Ironwood Pharmaceuticals, Inc.

People needed

98

Starts

2023-03-28

Expected to finish

2025-02-06

Last updated by the study team

2025-02-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Velocity Clinical Research — Mobile, Alabama, United States
• Ironwood Research Center — Scottsdale, Arizona, United States
• Urological Associates of Southern Arizona — Tucson, Arizona, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• Ironwood Research Center — Fresno, California, United States
• American Institute of Research — Los Angeles, California, United States
• Tri Valley Urology Medical Group — Murrieta, California, United States
• UCI Health — Orange, California, United States
• Ironwood Research Center — San Diego, California, United States
• Solano Regional Medical Group Sutter Regional Medical Foundation — Vacaville, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Advanced Urology Institute-Daytona Beach — Daytona Beach, Florida, United States
• Valencia Medical and Research Center — Miami, Florida, United States
• Clinical Associates of Orlando — Orlando, Florida, United States
• Altus Research — Palm Springs, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• South Tampa Health Services — Tampa, Florida, United States
• Ironwood Research Center — Cartersville, Georgia, United States
• Leavitt Clinical Research — Idaho Falls, Idaho, United States
• First Urology PSC — Jeffersonville, Indiana, United States
• Clinical Associates Midwest — Overland Park, Kansas, United States
• Wichita Urology - Newton — Wichita, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Ochsner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana, United States
• Urology Associates of Mobile — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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