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

April 1, 2024 updated by: Ironwood Pharmaceuticals, Inc.

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Ironwood Research Center
      • Tucson, Arizona, United States, 85715
    • California
      • Fresno, California, United States, 93720
        • Not yet recruiting
        • Ironwood Research Center
      • Los Angeles, California, United States, 90017
      • Murrieta, California, United States, 92562
      • Orange, California, United States, 92868
      • San Diego, California, United States, 92130
        • Not yet recruiting
        • Ironwood Research Center
      • Vacaville, California, United States, 95688
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
    • Georgia
      • Cartersville, Georgia, United States, 30120
        • Not yet recruiting
        • Ironwood Research Center
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
    • Kansas
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
    • Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • Ironwood Research Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • New Mexico Clinical Research and Osteoporosis Center
        • Contact:
    • New York
      • Albany, New York, United States, 12208
      • Garden City, New York, United States, 11530
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • The Arthur Smith Institute for Urology - New Hyde Park Location
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Ironwood Research Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Not yet recruiting
        • Ironwood Research Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
      • Gahanna, Ohio, United States, 43230
      • Zanesville, Ohio, United States, 43701
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Reading, Pennsylvania, United States, 19611
        • Not yet recruiting
        • Ironwood Research Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Ironwood Research Center
    • South Dakota
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Knoxville, Tennessee, United States, 37909
    • Texas
      • Dallas, Texas, United States, 75204
        • Not yet recruiting
        • Ironwood Research Center
      • Houston, Texas, United States, 77096
        • Not yet recruiting
        • Ironwood Research Center
      • Pearland, Texas, United States, 77584
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Active, not recruiting
        • The Chronic Pelvic Pain Center
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, Week 12
Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary
Baseline, Week 12
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
Time Frame: Baseline, 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
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
Time Frame: Baseline, Week 12
Frequency of TEAEs occurring in ≥2% of subjects
Baseline, Week 12
Overall frequency of TEAEs by severity grade
Time Frame: Baseline, Week 12
Overall frequency of TEAEs by severity grade
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ironwood Pharmaceuticals, Inc.

Investigators

  • Study Director: Medical Director, Ironwood Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 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)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3300-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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