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

Launched by IRONWOOD PHARMACEUTICALS, INC. · Feb 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IW-3300 for people who suffer from interstitial cystitis and bladder pain syndrome (IC/BPS). The main goal of the study is to find out if IW-3300 can help reduce bladder pain and other uncomfortable symptoms, such as burning or pressure in the bladder. Participants will be randomly assigned to receive either the study drug or a placebo (a non-active treatment) over a period of 12 weeks.

To be eligible for this trial, participants must have been diagnosed with IC/BPS and experience chronic bladder pain. They should also have other urinary symptoms, like needing to go to the bathroom more than usual at night or during the day. Participants will need to be willing to use a rectal foam product daily. It's important to note that certain medical conditions, recent surgeries, or other concerns may prevent someone from joining the study. For those who qualify, this trial offers a chance to explore a potential new treatment option for managing bladder pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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