Interstitial Cystitis Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | November 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Urological Institute of Northeast New York | Albany | New York |
United States | New Mexico Clinical Research and Osteoporosis Center | Albuquerque | New Mexico |
United States | MidLantic Urology | Bala-Cynwyd | Pennsylvania |
United States | Ironwood Research Center | Cartersville | Georgia |
United States | Ironwood Research Center | Charleston | South Carolina |
United States | Chattanooga Medical Research | Chattanooga | Tennessee |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | Ironwood Research Center | Dallas | Texas |
United States | Advanced Urology Institute-Daytona Beach | Daytona Beach | Florida |
United States | Ironwood Research Center | Fresno | California |
United States | Central Ohio Urology Group | Gahanna | Ohio |
United States | Accumed Research Associates | Garden City | New York |
United States | Ironwood Research Center | Hackensack | New Jersey |
United States | Ironwood Research Center | Houston | Texas |
United States | Leavitt Clinical Research | Idaho Falls | Idaho |
United States | First Urology PSC | Jeffersonville | Indiana |
United States | New Phase Research & Development | Knoxville | Tennessee |
United States | American Institute of Research | Los Angeles | California |
United States | Valencia Medical and Research Center | Miami | Florida |
United States | Velocity Clinical Research | Mobile | Alabama |
United States | Tri Valley Urology Medical Group | Murrieta | California |
United States | The Arthur Smith Institute for Urology - New Hyde Park Location | New Hyde Park | New York |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Columbia University Irving Medical Center | New York | New York |
United States | Ironwood Research Center | New York | New York |
United States | Quality Clinical Research | Omaha | Nebraska |
United States | UCI Health | Orange | California |
United States | Clinical Associates of Orlando | Orlando | Florida |
United States | Clinical Associates Midwest | Overland Park | Kansas |
United States | Altus Research | Palm Springs | Florida |
United States | Advances In Health Inc | Pearland | Texas |
United States | Center for Pelvic Health and Urogynecology - Tower Health Medical Group | Reading | Pennsylvania |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Specialty Clinical Research of St. Louis-Objective Health | Saint Louis | Missouri |
United States | Highland Clinical Research | Salt Lake City | Utah |
United States | Ironwood Research Center | San Diego | California |
United States | Ironwood Research Center | Scottsdale | Arizona |
United States | Seattle Clinical Research Center | Seattle | Washington |
United States | Ochsner LSU Health Shreveport - Regional Urology | Shreveport | Louisiana |
United States | Sanford Research | Sioux Falls | South Dakota |
United States | Precision Clinical Research | Sunrise | Florida |
United States | South Tampa Health Services | Tampa | Florida |
United States | Michigan Institute of Urology | Troy | Michigan |
United States | Urological Associates of Southern Arizona | Tucson | Arizona |
United States | Solano Regional Medical Group Sutter Regional Medical Foundation | Vacaville | California |
United States | The Chronic Pelvic Pain Center | Vienna | Virginia |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Bay State Clinical Trials | Watertown | Massachusetts |
United States | Wichita Urology - Newton | Wichita | Kansas |
United States | Ironwood Research Center | Winston-Salem | North Carolina |
United States | Genesis Healthcare System | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ironwood Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary) | Baseline, Week 12 | |
Secondary | CFB in weekly average of a burning sensation in the bladder at its worst at Week 12 | Subject assessment of bladder burning sensation at its worst will be reported via an eDiary | Baseline, Week 12 | |
Secondary | CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12 | Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary | Baseline, Week 12 | |
Secondary | CFB in weekly average of discomfort in the bladder at its worst at Week 12 | Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary | Baseline, Week 12 | |
Secondary | CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12 | The GUPI assesses the degree of symptoms 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 | Baseline, Week 12 | |
Secondary | Frequency of Treatment-emergent adverse events (TEAEs) occurring in =2% of subjects | Frequency of TEAEs occurring in =2% of subjects | Baseline, Week 12 | |
Secondary | Overall frequency of TEAEs by severity grade | Overall frequency of TEAEs by severity grade | Baseline, Week 12 |
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