Interstitial CystitisPhase 2NCT05740007
A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
A Phase 2 study testing IW-3300 rectal foam in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Ironwood Pharmaceuticals, Inc. at 53 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- IW-3300 rectal foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 53 sitesUnited States
- Study dates
- 28 Mar 2023to 6 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Urological Institute of Northeast New York
Albany, New York, 12208
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, 87106
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Ironwood Research Center
Cartersville, Georgia, 30120
Ironwood Research Center
Charleston, South Carolina, 29425
Chattanooga Medical Research
Chattanooga, Tennessee, 37404
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Advanced Urology Institute-Daytona Beach
Daytona Beach, Florida, 32114
Ironwood Research Center
Fresno, California, 93720
Central Ohio Urology Group
Gahanna, Ohio, 43230
Accumed Research Associates
Garden City, New York, 11530
Ironwood Research Center
Hackensack, New Jersey, 07601
Houston Metro Urology
Houston, Texas, 77027
Baylor College of Medicine
Houston, Texas, 77096
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
First Urology PSC
Jeffersonville, Indiana, 47130
New Phase Research & Development
Knoxville, Tennessee, 37909
Arkansas Urology
Little Rock, Arkansas, 72211
American Institute of Research
Los Angeles, California, 90017
Valencia Medical and Research Center
Miami, Florida, 33165
Urology Associates of Mobile
Mobile, Alabama, 33608
Velocity Clinical Research
Mobile, Alabama, 36608
Tri Valley Urology Medical Group
Murrieta, California, 92562
The Arthur Smith Institute for Urology - New Hyde Park Location
New Hyde Park, New York, 11042
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Columbia University Irving Medical Center
New York, New York, 10032
Ironwood Research Center
New York, New York, 10065
Quality Clinical Research
Omaha, Nebraska, 68114
UCI Health
Orange, California, 92868
Clinical Associates of Orlando
Orlando, Florida, 32801
Clinical Associates Midwest
Overland Park, Kansas, 66214
Altus Research
Palm Springs, Florida, 33406
Advances In Health Inc
Pearland, Texas, 77584
Center for Pelvic Health and Urogynecology - Tower Health Medical Group
Reading, Pennsylvania, 19611
William Beaumont Hospital
Royal Oak, Michigan, 48073
Highland Clinical Research
Salt Lake City, Utah, 84124
Ironwood Research Center
San Diego, California, 92130
Ironwood Research Center
Scottsdale, Arizona, 85259
Seattle Clinical Research Center
Seattle, Washington, 98105
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, 71106
Sanford Research
Sioux Falls, South Dakota, 57105
Specialty Clinical Research of St. Louis-Objective Health
St Louis, Missouri, 63141
Precision Clinical Research
Sunrise, Florida, 33351
South Tampa Health Services
Tampa, Florida, 33609
Michigan Institute of Urology
Troy, Michigan, 48084
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Solano Regional Medical Group Sutter Regional Medical Foundation
Vacaville, California, 95688
The Chronic Pelvic Pain Center
Vienna, Virginia, 22182
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Bay State Clinical Trials
Watertown, Massachusetts, 02472
Wichita Urology - Newton
Wichita, Kansas, 67226
Atrium Health Wake Forest Baptist Medical Center - Urology
Winston-Salem, North Carolina, 27103
Genesis Healthcare System
Zanesville, Ohio, 43701
About this study
Official title: 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.
Read the 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.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- IW-3300 rectal foam, Placebo
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IW-3300 rectal foamDrug
IW-3300 rectal foam administered daily for 12 weeks
PlaceboDrug
Placebo rectal foam administered daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| IW-3300 100 µg | Experimental | IW-3300 at 100 µg rectal foam administered daily for 12 weeks Receives: Drug: IW-3300 rectal foam |
| IW-3300 300 µg | Experimental | IW-3300 at 300 µg rectal foam administered daily for 12 weeks Receives: Drug: IW-3300 rectal foam |
| Placebo | Placebo comparator | Placebo rectal foam administered daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, Week 12
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Week 12
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
Frequency of TEAEs occurring in ≥2% of subjects
Measured: Baseline, Week 12
Overall frequency of TEAEs by severity grade
Overall frequency of TEAEs by severity grade
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start28 Mar 2023
- Primary completion23 Jan 2025
- Study completion6 Feb 2025
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Ironwood Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740007
- Sponsor's protocol ID
- C3300-201
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05740007
- Acronym / sponsor ID
- C3300-201
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IW-3300 100 µg | Experimental | Drug: IW-3300 rectal foamIW-3300 at 100 µg rectal foam administered daily for 12 weeks |
| IW-3300 300 µg | Experimental | Drug: IW-3300 rectal foamIW-3300 at 300 µg rectal foam administered daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo rectal foam administered daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IW-3300 rectal foamIW-3300 rectal foam administered daily for 12 weeks | Drug | IW-3300 100 µg, IW-3300 300 µg |
| PlaceboPlacebo rectal foam administered daily for 12 weeks | Drug | Placebo |
Primary outcome
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)
6 secondary outcomes
CFB in weekly average of a burning sensation in the bladder at its worst at Week 12
Time frame: 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
CFB in weekly average of discomfort in the bladder at its worst at Week 12
Time frame: Baseline, Week 12
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
Time frame: Baseline, Week 12
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
Time frame: Baseline, Week 12
Overall frequency of TEAEs by severity grade
Time frame: Baseline, Week 12
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Ironwood Pharmaceuticals
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IW-3300 rectal foam in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Ironwood Pharmaceuticals, Inc. at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.