A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
- Conditions
- Interstitial CystitisBladder Pain Syndrome
- Interventions
- Drug: PlaceboDrug: IW-3300 rectal foam
- Registration Number
- NCT05740007
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo rectal foam administered daily for 12 weeks IW-3300 100 µg IW-3300 rectal foam IW-3300 at 100 µg rectal foam administered daily for 12 weeks IW-3300 300 µg IW-3300 rectal foam IW-3300 at 300 µg rectal foam administered daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12 Baseline, Week 12 Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)
- Secondary Outcome Measures
Name Time Method CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12 Baseline, Week 12 The GUPI assesses the degree of symptoms in both men and women with genitourinary pain complaints over the last week, including experience of pain or discomfort in various areas, frequency of pain/discomfort, average pain/discomfort, frequency of urinary symptoms, and quality of life (QoL) impact
CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12 Baseline, Week 12 Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects Baseline, Week 12 Frequency of TEAEs occurring in ≥2% of subjects
Overall frequency of TEAEs by severity grade Baseline, Week 12 Overall frequency of TEAEs by severity grade
CFB in weekly average of a burning sensation in the bladder at its worst at Week 12 Baseline, Week 12 Subject assessment of bladder burning sensation at its worst will be reported via an eDiary
CFB in weekly average of discomfort in the bladder at its worst at Week 12 Baseline, Week 12 Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary
Trial Locations
- Locations (47)
Urology Associates of Mobile
🇺🇸Mobile, Alabama, United States
Velocity Clinical Research
🇺🇸Mobile, Alabama, United States
Ironwood Research Center
🇺🇸Charleston, South Carolina, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, 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
Solano Regional Medical Group Sutter Regional Medical Foundation
🇺🇸Vacaville, California, United States
MedStar Washington Hospital Center
🇺🇸Washington, 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
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
Bay State Clinical Trials
🇺🇸Watertown, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
Specialty Clinical Research of St. Louis-Objective Health
🇺🇸Saint Louis, Missouri, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
New Mexico Clinical Research and Osteoporosis Center
🇺🇸Albuquerque, New Mexico, United States
Urological Institute of Northeast New York
🇺🇸Albany, New York, United States
Accumed Research Associates
🇺🇸Garden City, New York, United States
The Arthur Smith Institute for Urology - New Hyde Park Location
🇺🇸New Hyde Park, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center - Urology
🇺🇸Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Central Ohio Urology Group
🇺🇸Gahanna, Ohio, United States
Genesis Healthcare System
🇺🇸Zanesville, Ohio, United States
MidLantic Urology
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Center for Pelvic Health and Urogynecology - Tower Health Medical Group
🇺🇸Reading, Pennsylvania, United States
Sanford Research
🇺🇸Sioux Falls, South Dakota, United States
Chattanooga Medical Research
🇺🇸Chattanooga, Tennessee, United States
New Phase Research & Development
🇺🇸Knoxville, Tennessee, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Advances In Health Inc
🇺🇸Pearland, Texas, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
The Chronic Pelvic Pain Center
🇺🇸Vienna, Virginia, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States