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

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.

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

• 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, rectal, 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

• Has received a cystoscopy (with or without hydrodistension for reason other than pain relief) for diagnostic purposes within the past 30 days or a cystoscopy involving therapeutic hydrodistension (for pain relief) within the past 90 days

• Has history of pelvic irradiation or radiation cystitis

• Has a recent history of drug or alcohol abuse