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

C3300-201

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.

2023-03-28

2025-10-01

2025-11-01

Recruiting

Early phase I

300

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2024-05-31