All > New Mexico > Knoxville

IW-3300 100 µg for Interstitial Cystitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ironwood Research Center, Sunrise, FLInterstitial Cystitis+1 MoreIW-3300 rectal foam - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Interstitial Cystitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
1
BOTOX
1
Pelvic Floor Physical Therapy

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Baseline, Week 12

Baseline, Week 12
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
CFB in weekly average of discomfort in the bladder at its worst at Week 12
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
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
Overall frequency of TEAEs by severity grade

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
2
BOTOX
2
Pelvic Floor Physical Therapy

Trial Design

3 Treatment Groups

IW-3300 100 µg
1 of 3
IW-3300 300 µg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

300 Total Participants · 3 Treatment Groups

Primary Treatment: IW-3300 100 µg · Has Placebo Group · Phase 2

IW-3300 100 µg
Drug
Experimental Group · 1 Intervention: IW-3300 rectal foam · Intervention Types: Drug
IW-3300 300 µg
Drug
Experimental Group · 1 Intervention: IW-3300 rectal foam · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12

Who is running the clinical trial?

Ironwood Pharmaceuticals, Inc.Lead Sponsor
40 Previous Clinical Trials
16,636 Total Patients Enrolled
George Dukes, PhDStudy DirectorIronwood Pharmaceuticals

Eligibility Criteria

Age 18 - 70 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) is less than or equal to 40 kg/m2.
You have been experiencing constant bladder pain when your bladder is full for the past 6 months.
You must fill out an electronic diary regularly and report the severity of your worst bladder pain each week before starting the treatment.
You have experienced frequent urination and/or an urgent need to urinate during the day or night in the past 6 months.
You are comfortable using a medication that needs to be inserted into your rectum once a day for 12 weeks.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top