A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
NCT05740007 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2025-02-28
Summary
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 question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.
Conditions
- Interstitial Cystitis
- Bladder Pain Syndrome
Interventions
- DRUG
-
IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks
- DRUG
-
Placebo rectal foam administered daily for 12 weeks
Sponsors & Collaborators
-
Ironwood Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Ironwood Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-28
- Primary Completion
- 2025-01-23
- Completion
- 2025-02-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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