What side effects are associated with this type of intervention?

Common treatments for Interstitial Cystitis (IC) include pentosan polysulfate sodium (PPS), cyclosporine A (CyA), and bladder hydrodistention. PPS can cause side effects like gastrointestinal disturbances, hair loss, and liver function abnormalities. CyA is associated with higher rates of adverse effects, including nephrotoxicity, hypertension, and increased risk of infections. Bladder hydrodistention may lead to temporary worsening of symptoms, bladder perforation, and bleeding. Analgesics used for IC can cause gastrointestinal issues and dependency, while intravesical therapies may result in bladder irritation and discomfort.

What prior FDA approvals exist?

For the treatment of Interstitial Cystitis (IC), the FDA has approved pentosan polysulfate sodium (PPS), which helps restore the bladder lining and reduce symptoms like pain and urinary frequency. Cyclosporine A (CyA) is also used off-label for its immunosuppressive properties to manage IC symptoms. These treatments aim to alleviate the chronic pain and discomfort associated with IC.

What other types of research exist?

Promising novel alternatives to IW-3300 for Interstitial Cystitis patients include extracorporeal shock wave therapy (ECSW) and innovative intravesical drug administration methods. ECSW has shown potential in reducing inflammation and oxidative stress, while intravesical drug administration allows for targeted delivery of therapeutic agents directly into the bladder.

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IW-3300 for Interstitial Cystitis

Phase 2

Waitlist Available

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

Summary

This trial is testing a new drug called IW-3300 to see if it can help people with chronic bladder pain. The drug is given as a rectal foam and aims to relieve symptoms like pain, burning, and pressure. Patients will use the drug at home for a few months.

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.

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.

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 below

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I have been diagnosed with IC/BPS by a specialist.

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I have had bladder pain when it fills for over 6 months.

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You must fill out an electronic diary regularly and report the severity of your worst bladder pain each week before starting the treatment.

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I experience frequent urination at night or during the day, or I feel a sudden urge to urinate.

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Your body mass index (BMI) is less than or equal to 40 kg/m2.

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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

This trial's timeline: 7 days for screening, 12 weeks for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Trial 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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Interstitial Cystitis (IC) include intravesical instillations, oral medications, and physical therapies. Intravesical instillations, such as lidocaine with heparin, work by directly delivering pain-relieving and anti-inflammatory agents to the bladder lining, which helps reduce pain and inflammation. Oral medications like NSAIDs and acetaminophen are used to manage mild to moderate pain by reducing inflammation systemically. Physical therapies, particularly pelvic floor physical therapy, aim to relieve muscle spasms and tension that can exacerbate IC symptoms. These treatments are crucial for IC patients as they target different aspects of the condition, providing a multifaceted approach to pain relief and symptom management.

Impact of intravesical hyaluronic acid treatment on bladder inflammation in interstitial cystitis rat model.Effects of hyperbaric oxygen therapy on hydrochloric acid-induced interstitial cystitis in rats: a histological and ultrastructural study.P2X and P2X receptor expression in human bladder urothelium and changes in interstitial cystitis.