IW-3300 for Interstitial Cystitis

No longer recruiting at 90 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if IW-3300, a rectal foam, is safe and effective for individuals with interstitial cystitis/bladder pain syndrome (IC/BPS), which causes bladder pain and discomfort. Participants will randomly receive either the IW-3300 foam or a placebo (a substance with no active ingredients) for 12 weeks. The trial seeks individuals diagnosed with IC/BPS who have experienced chronic bladder pain and symptoms like frequent urination or urgency for the past six months. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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.

Is there any evidence suggesting that IW-3300 is likely to be safe for humans?

Research has shown that IW-3300 is currently being tested for safety in treating interstitial cystitis, a condition causing bladder pain. While earlier studies provide limited detailed safety information on IW-3300, the current trial is in an early stage. Initial tests have indicated it is somewhat safe for humans. However, further research is necessary to confirm its tolerability and identify any potential side effects. Participants will help determine if IW-3300 is safe and effective in relieving symptoms such as bladder burning, pressure, and discomfort. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for interstitial cystitis?

Unlike the standard treatments for interstitial cystitis, which often include oral medications or bladder instillations, IW-3300 is unique due to its delivery method as a rectal foam. This method can offer more targeted relief by potentially affecting pelvic nerve pathways associated with bladder pain. Researchers are excited about IW-3300 because it may provide a new approach to managing symptoms with different dosing options, potentially offering more tailored treatment plans for patients with varying severity of symptoms.

What evidence suggests that IW-3300 might be an effective treatment for interstitial cystitis?

Research has shown that IW-3300 might help relieve symptoms of interstitial cystitis, a condition causing bladder pain and discomfort. Early results suggest that IW-3300 could reduce pain in internal organs by affecting nerve communication. This trial tests IW-3300 as a rectal foam at different dosages to evaluate its ability to ease bladder pain and related symptoms. Although detailed information from human studies remains limited, this new approach appears promising for symptom relief. More research is needed to confirm these early findings. ^{1 2 4 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Ironwood Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05740007?term=AREA%5BNCTIdSearch%5D(NCT05740007)&rank=1

A Phase 2 Study of IW-3300 for the Treatment of Bladder ... 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).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05740007?tab=history&a=4

Record History | ver. 4: 2023-03-08 | NCT05740007 A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/​Bladder Pain Syndrome ... Sponsor Ironwood Pharmaceuticals, ...

3. withpower.com withpower.com/trial/phase-2-cystitis-2-2023-e8373

IW-3300 for Interstitial Cystitis · Info for Participants 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 ...

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05740007/

Trial | NCT05740007 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).

5. investor.ironwoodpharma.com investor.ironwoodpharma.com/press-releases/press-release-details/2022/Ironwood-Presents-New-Data-Demonstrating-Potential-of-IW-3300-for-Visceral-Pain-at-Digestive-Disease-Week-DDW-2022/default.aspx

Press Release Details “These results are exciting because they show the potential of IW-3300 to relieve visceral pain via a neuronal cross-talk mechanism mediated ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05740007?tab=history&a=22

Record History | ver. 22: 2023-10-16 | NCT05740007 A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/​Bladder Pain Syndrome · Study Record Versions · Study ...

7. northwell.edu northwell.edu/clinical-trials/23-0155

IW?3300 for Treatment of Bladder Pain in Interstitial Cystitis 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 ...