IW-3300 for Interstitial Cystitis

Recruiting at 88 trial locations

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ironwood Pharmaceuticals, Inc.

Disqualifiers: Cancer, Bladder tumors, UTIs, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

98 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What makes the drug IW-3300 rectal foam unique for treating interstitial cystitis?

IW-3300 rectal foam is unique because it is administered rectally, which is different from many other treatments for interstitial cystitis that are typically oral or bladder instillations. This novel route of administration may offer a different mechanism of action or absorption profile, potentially providing relief for patients who have not responded to standard treatments. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Ironwood Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion 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 am currently being treated for or have a history of cancer in my reproductive or pelvic area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Pretreatment

Participants undergo pretreatment procedures before starting the study drug

Up to 3 weeks

1 visit (in-person)

Treatment

Participants receive either IW-3300 or placebo rectal foam daily for 12 weeks

12 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 follow-up phone call

Treatment Details

Interventions

• IW-3300 rectal foam
• Placebo

Trial Overview 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.

Participant Groups

Group I: IW-3300 300 µg Experimental Treatment 1 Intervention

IW-3300 at 300 µg rectal foam administered daily for 12 weeks

Group II: IW-3300 100 µg Experimental Treatment 1 Intervention

IW-3300 at 100 µg rectal foam administered daily for 12 weeks

Group III: Placebo Placebo Group 1 Intervention

Placebo rectal foam administered daily for 12 weeks

Who Is Running the Clinical Trial?

Ironwood Pharmaceuticals, Inc.

Lead Sponsor

Trials

42

Recruited

17,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of In Vitro-In Vivo Correlation for Potassium Chloride Extended Release Tablet Formulation Using Urinary Pharmacokinetic Data. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Measuring dilution of microbicide gels with optical imaging. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Open-Label, Crossover Phase 1 Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel (the CHARM-03 Study). [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Transdermal penetration of diclofenac after multiple epicutaneous administration. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterization of a potential universal placebo designed for use in vaginal microbicide clinical trials. [2007]