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

February 26, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
Time Frame: Baseline, 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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ironwood Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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