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IW-3300 for Interstitial Cystitis
Phase 2
Recruiting
Research Sponsored by Ironwood Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 7 days
Treatment 12 weeks
Follow Up 7 weeks
Awards & highlights
Study Summary
This trial will study the safety & effectiveness of IW-3300 for treating IC/BPS symptoms like bladder pain, burning, pressure, & discomfort. Subjects will get either the drug or placebo.
Who is the study for?
This trial is for individuals diagnosed with interstitial cystitis/bladder pain syndrome by a specialist, experiencing chronic bladder pain and urinary symptoms like frequent nighttime urination or urgency. Participants must have a BMI of 40 or less, be able to use rectal foam daily for 12 weeks, and keep an eDiary of their bladder pain. People with pelvic radiation history, active cancer treatment, major psychiatric conditions, contraindications to rectal foam use, recent substance abuse or certain male-specific conditions cannot join.Check my eligibility
What is being tested?
The study tests IW-3300 rectal foam against a placebo to see if it safely reduces bladder pain and related symptoms in people with interstitial cystitis/bladder pain syndrome. Participants will randomly receive either the actual medication or placebo without knowing which one they are getting.See study design
What are the potential side effects?
While specific side effects of IW-3300 are not listed here, typical reactions may include local irritation at the application site (rectum), potential allergic reactions to ingredients in the foam formulation, gastrointestinal discomforts such as bloating or cramps.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with IC/BPS by a specialist.
Select...
I have had bladder pain when it fills for over 6 months.
Select...
You must fill out an electronic diary regularly and report the severity of your worst bladder pain each week before starting the treatment.
Select...
I experience frequent urination at night or during the day, or I feel a sudden urge to urinate.
Select...
Your body mass index (BMI) is less than or equal to 40 kg/m2.
Select...
I am willing to use a rectal product daily for 12 weeks.
Timeline
Screening ~ 7 days1 visit
Treatment ~ 12 weeks6 visits
Follow Up ~ 7 weeks1 visit
Screening ~ 7 days
Treatment ~ 12 weeks
Follow Up ~7 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
CFB in weekly average of a burning sensation in the bladder at its worst at Week 12
CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: IW-3300 300 µgExperimental Treatment1 Intervention
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
Group II: IW-3300 100 µgExperimental Treatment1 Intervention
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo rectal foam administered daily for 12 weeks
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Ironwood Pharmaceuticals, Inc.Lead Sponsor
41 Previous Clinical Trials
16,729 Total Patients Enrolled
George Dukes, PhDStudy DirectorIronwood Pharmaceuticals
Medical DirectorStudy DirectorIronwood Pharmaceuticals
2,777 Previous Clinical Trials
8,063,588 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot use rectal foam due to a health condition.I do not have an uncontrolled major psychiatric condition or a recent suicide attempt.I have had bladder pain when it fills for over 6 months.I have been diagnosed with IC/BPS by a specialist.I experience frequent urination at night or during the day, or I feel a sudden urge to urinate.You must fill out an electronic diary regularly and report the severity of your worst bladder pain each week before starting the treatment.I am currently being treated for or have a history of cancer in my reproductive or pelvic area.I am willing to use a rectal product daily for 12 weeks.Your body mass index (BMI) is less than or equal to 40 kg/m2.You have a recent history of abusing drugs or alcohol.I have had bacterial prostatitis or an enlarged prostate.I have had radiation treatment in my pelvic area.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: IW-3300 300 µg
- Group 3: IW-3300 100 µg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 7 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 7 Weeks after you stop receiving the treatment.
Interstitial Cystitis Patient Testimony for trial: Trial Name: NCT05740007 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any capacity for new enrollees in this experiment?
"As verified by clinicaltrials.gov, this medical trial opened for patient recruitment on March 1st 2023 and was last updated a couple days ago."
Answered by AI
Am I eligible to take part in this research project?
"This clinical trial is seeking 300 individuals with interstitial cystitis, aged between 18 to 70 years of age."
Answered by AI
Has IW-3300 100 µg achieved regulatory approval from the FDA?
"As this is a Phase 2 trial with some evidence supporting its safety, our evaluation placed IW-3300 100 µg at a score of two. However, efficacy data has yet to be established for this drug."
Answered by AI
Are there any age restrictions for those wishing to participate in the trial?
"The age eligibility range for this trial is 18 to 70. For those younger than 18, there are 383 other trials available; and similarly, 1011 studies can be found for those over 65 years of age."
Answered by AI
How many subjects are enrolled in this investigation?
"Yes, according to the data hosted on clinicaltrials.gov, this medical trial is actively searching for volunteers. It was initially posted on March 1st of 2023 and subsequently updated most recently on March 3rd of that same year. The research team needs 300 patients from 2 separate sites in order to meet their enrollment goals."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Texas
Arizona
What site did they apply to?
Ironwood Research Center
Ironwood Research Site
Urological Associates of Southern Arizona
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
I am frustrated and tired of UTI's and bladder pain. I’ve been suffering from this condition for over 10 years. I’m eager to find a new effective treatment.
PatientReceived 1 prior treatment
I want to stop hurting and occasionally pee on myself when I have to pee. I have to wear pee pads and i am 43 years old. I want to really know what is going on with me. I can't enjoy myself anymore when I go to family functions and i would like to be able to go swimming with my grandson and my baby girl but I can't. Please help me!!
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Will the suppository create any issues with bowel movement?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Urological Associates of Southern Arizona: < 48 hours
Average response time
- < 2 Days
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