A Phase 2 interventional study of IW-3300 rectal foam and Placebo in Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Ironwood Pharmaceuticals, Inc.. Terminated at 53 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Ironwood Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 weeks.
227 studies on the registry are indexed under Cystitis, Interstitial; 32 are open to participants now.
This study's enrollment of 98 is above the median of 50 across 152 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Ironwood Pharmaceuticals, Inc. is the lead sponsor of 25 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
Drug: IW-3300 rectal foam
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
Drug: IW-3300 rectal foam
Placebo rectal foam administered daily for 12 weeks
Drug: Placebo
IW-3300 rectal foam administered daily for 12 weeks
Placebo rectal foam administered daily for 12 weeks
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
Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)
Time frame: Baseline, Week 12
CFB in weekly average of a burning sensation in the bladder at its worst at Week 12
Subject assessment of bladder burning sensation at its worst will be reported via an eDiary
Time frame: Baseline, Week 12
CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12
Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary
Time frame: Baseline, Week 12
CFB in weekly average of discomfort in the bladder at its worst at Week 12
Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary
Time frame: Baseline, Week 12
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
The GUPI assesses the degree of symptoms in both men and women with genitourinary pain complaints over the last week, including experience of pain or discomfort in various areas, frequency of pain/discomfort, average pain/discomfort, frequency of urinary symptoms, and quality of life (QoL) impact
Time frame: Baseline, Week 12
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
Frequency of TEAEs occurring in ≥2% of subjects
Time frame: Baseline, Week 12
Overall frequency of TEAEs by severity grade
Overall frequency of TEAEs by severity grade
Time frame: Baseline, Week 12
Plan to share: Yes — Ironwood Pharmaceuticals, Inc. is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to deidentified/pseudonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, statistical analysis plans, clinical study report synopses) for Phase 2 through 4 trials that are not part of an ongoing or planned regulatory submission or are from a terminated program.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Access criteria: These clinical trial data can be requested by any qualified researchers who engages in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data user agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the link below.
Data sharing details ↗ · ironwoodpharma.com
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: IW-3300
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