A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
NCT ID: NCT05740007
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
98 participants
INTERVENTIONAL
2023-03-28
2025-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IW-3300 100 µg
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks
IW-3300 300 µg
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks
Placebo
Placebo rectal foam administered daily for 12 weeks
Placebo
Placebo rectal foam administered daily for 12 weeks
Interventions
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IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks
Placebo
Placebo rectal foam administered daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Ironwood Pharmaceuticals
Locations
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Urology Associates of Mobile
Mobile, Alabama, United States
Velocity Clinical Research
Mobile, Alabama, United States
Ironwood Research Center
Scottsdale, Arizona, United States
Urological Associates of Southern Arizona
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Ironwood Research Center
Fresno, California, 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
Ironwood Research Center
San Diego, California, United States
Solano Regional Medical Group Sutter Regional Medical Foundation
Vacaville, California, United States
MedStar Washington Hospital Center
Washington D.C., 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
Ironwood Research Center
Cartersville, Georgia, 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
St Louis, Missouri, United States
Quality Clinical Research
Omaha, Nebraska, United States
Ironwood Research Center
Hackensack, New Jersey, 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
Ironwood Research 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
Ironwood Research Center
Charleston, South Carolina, 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
Countries
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Other Identifiers
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C3300-201
Identifier Type: -
Identifier Source: org_study_id
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