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

NCT05740007 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: C3300-201
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 53

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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• CFB in weekly average of a burning sensation in the bladder at its worst at Week 12

  Baseline, Week 12

• CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12

  Baseline, Week 12

• CFB in weekly average of discomfort in the bladder at its worst at Week 12

  Baseline, Week 12

• CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12

  Baseline, Week 12

• Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects

  Baseline, Week 12

Study Arms (3)

IW-3300 100 µg

EXPERIMENTAL

IW-3300 at 100 µg rectal foam administered daily for 12 weeks

Drug: IW-3300 rectal foam

IW-3300 300 µg

EXPERIMENTAL

IW-3300 at 300 µg rectal foam administered daily for 12 weeks

Drug: IW-3300 rectal foam

Placebo

PLACEBO COMPARATOR

Placebo rectal foam administered daily for 12 weeks

Drug: Placebo

Interventions

IW-3300 rectal foam DRUG

IW-3300 rectal foam administered daily for 12 weeks

IW-3300 100 µg; IW-3300 300 µg

Placebo DRUG

Placebo rectal foam administered daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead

Study Sites (53)

Urology Associates of Mobile

Mobile, Alabama, 33608, United States

Location

Velocity Clinical Research

Mobile, Alabama, 36608, United States

Location

Ironwood Research Center

Scottsdale, Arizona, 85259, United States

Location

Urological Associates of Southern Arizona

Tucson, Arizona, 85715, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Ironwood Research Center

Fresno, California, 93720, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

UCI Health

Orange, California, 92868, United States

Location

Ironwood Research Center

San Diego, California, 92130, United States

Location

Solano Regional Medical Group Sutter Regional Medical Foundation

Vacaville, California, 95688, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Advanced Urology Institute-Daytona Beach

Daytona Beach, Florida, 32114, United States

Location

Valencia Medical and Research Center

Miami, Florida, 33165, United States

Location

Clinical Associates of Orlando

Orlando, Florida, 32801, United States

Location

Altus Research

Palm Springs, Florida, 33406, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

South Tampa Health Services

Tampa, Florida, 33609, United States

Location

Ironwood Research Center

Cartersville, Georgia, 30120, United States

Location

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

First Urology PSC

Jeffersonville, Indiana, 47130, United States

Location

Clinical Associates Midwest

Overland Park, Kansas, 66214, United States

Location

Wichita Urology - Newton

Wichita, Kansas, 67226, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Bay State Clinical Trials

Watertown, Massachusetts, 02472, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

Specialty Clinical Research of St. Louis-Objective Health

St Louis, Missouri, 63141, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Ironwood Research Center

Hackensack, New Jersey, 07601, United States

Location

New Mexico Clinical Research and Osteoporosis Center

Albuquerque, New Mexico, 87106, United States

Location

Urological Institute of Northeast New York

Albany, New York, 12208, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

The Arthur Smith Institute for Urology - New Hyde Park Location

New Hyde Park, New York, 11042, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Ironwood Research Center

New York, New York, 10065, United States

Location

Atrium Health Wake Forest Baptist Medical Center - Urology

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Central Ohio Urology Group

Gahanna, Ohio, 43230, United States

Location

Genesis Healthcare System

Zanesville, Ohio, 43701, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Center for Pelvic Health and Urogynecology - Tower Health Medical Group

Reading, Pennsylvania, 19611, United States

Location

Ironwood Research Center

Charleston, South Carolina, 29425, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57105, United States

Location

Chattanooga Medical Research

Chattanooga, Tennessee, 37404, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

Baylor College of Medicine

Houston, Texas, 77096, United States

Location

Advances In Health Inc

Pearland, Texas, 77584, United States

Location

Highland Clinical Research

Salt Lake City, Utah, 84124, United States

Location

The Chronic Pelvic Pain Center

Vienna, Virginia, 22182, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Ironwood Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: March 28, 2023
• Primary Completion: January 23, 2025
• Study Completion: February 6, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Access Criteria: These clinical trial data can be requested by any qualified researchers who engages in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data user agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the link below.

Locations

US (53)