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

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.

Study Overview

• Status: Terminated
• Conditions: Interstitial Cystitis; Bladder Pain Syndrome
• Intervention / Treatment: Drug: IW-3300 rectal foam; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Velocity Clinical Research
    • Mobile, Alabama, United States, 33608
      • Urology Associates of Mobile
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Ironwood Research Center
    • Tucson, Arizona, United States, 85715
      • Urological Associates of Southern Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • California
    • Fresno, California, United States, 93720
      • Ironwood Research Center
    • Los Angeles, California, United States, 90017
      • American Institute of Research
    • Murrieta, California, United States, 92562
      • Tri Valley Urology Medical Group
    • Orange, California, United States, 92868
      • UCI Health
    • San Diego, California, United States, 92130
      • Ironwood Research Center
    • Vacaville, California, United States, 95688
      • Solano Regional Medical Group Sutter Regional Medical Foundation
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Institute-Daytona Beach
    • Miami, Florida, United States, 33165
      • Valencia Medical and Research Center
    • Orlando, Florida, United States, 32801
      • Clinical Associates of Orlando
    • Palm Springs, Florida, United States, 33406
      • Altus Research
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • Tampa, Florida, United States, 33609
      • South Tampa Health Services
  • Georgia
    • Cartersville, Georgia, United States, 30120
      • Ironwood Research Center
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology PSC
  • Kansas
    • Overland Park, Kansas, United States, 66214
      • Clinical Associates Midwest
    • Wichita, Kansas, United States, 67226
      • Wichita Urology - Newton
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • Shreveport, Louisiana, United States, 71106
      • Ochsner LSU Health Shreveport - Regional Urology
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Specialty Clinical Research of St. Louis-Objective Health
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Ironwood Research Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research and Osteoporosis Center
  • New York
    • Albany, New York, United States, 12208
      • Urological Institute of Northeast New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New Hyde Park, New York, United States, 11042
      • The Arthur Smith Institute for Urology - New Hyde Park Location
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • New York, New York, United States, 10065
      • Ironwood Research Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Atrium Health Wake Forest Baptist Medical Center - Urology
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Gahanna, Ohio, United States, 43230
      • Central Ohio Urology Group
    • Zanesville, Ohio, United States, 43701
      • Genesis HealthCare System
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
    • Reading, Pennsylvania, United States, 19611
      • Center for Pelvic Health and Urogynecology - Tower Health Medical Group
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Ironwood Research Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research & Development
  • Texas
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • Houston, Texas, United States, 77096
      • Baylor College of Medicine
    • Pearland, Texas, United States, 77584
      • Advances In Health Inc
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
  • Virginia
    • Vienna, Virginia, United States, 22182
      • The Chronic Pelvic Pain Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IW-3300 100 µg; IW-3300 at 100 µg rectal foam administered daily for 12 weeks	Drug: IW-3300 rectal foam; IW-3300 rectal foam administered daily for 12 weeks
Experimental: IW-3300 300 µg; IW-3300 at 300 µg rectal foam administered daily for 12 weeks	Drug: IW-3300 rectal foam; IW-3300 rectal foam administered daily for 12 weeks
Placebo Comparator: Placebo; Placebo rectal foam administered daily for 12 weeks	Drug: Placebo; Placebo rectal foam administered daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects	Frequency of TEAEs occurring in ≥2% of subjects	Baseline, Week 12
Overall frequency of TEAEs by severity grade	Overall frequency of TEAEs by severity grade	Baseline, Week 12
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at 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	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Ironwood Pharmaceuticals, Inc.
• Investigators: Study Director: Medical Director, Ironwood Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): February 6, 2025

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Urinary Bladder Diseases; Somatoform Disorders; Syndrome; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: C3300-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Ironwood Pharmaceuticals, Inc. is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to deidentified/pseudonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, statistical analysis plans, clinical study report synopses) for Phase 2 through 4 trials that are not part of an ongoing or planned regulatory submission or are from a terminated program.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No