Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
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ClinicalTrials.gov Identifier: NCT05740007 |
Recruitment Status :
Recruiting
First Posted : February 22, 2023
Last Update Posted : May 2, 2024
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Condition or disease | Intervention/treatment | Phase |
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Interstitial Cystitis Bladder Pain Syndrome | Drug: IW-3300 rectal foam Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate the Efficacy, Safety, and Tolerability of 2 Dose Levels of IW-3300 Administered Rectally for 12 Weeks to Treat Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome |
Actual Study Start Date : | March 28, 2023 |
Estimated Primary Completion Date : | October 2025 |
Estimated Study Completion Date : | November 2025 |
Arm | Intervention/treatment |
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Experimental: IW-3300 100 µg
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
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Drug: IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks |
Experimental: IW-3300 300 µg
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
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Drug: IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks |
Placebo Comparator: Placebo
Placebo rectal foam administered daily for 12 weeks
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Drug: Placebo
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 [ Time Frame: Baseline, Week 12 ]Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)
- CFB in weekly average of a burning sensation in the bladder at its worst at Week 12 [ Time Frame: Baseline, Week 12 ]Subject assessment of bladder burning sensation at its worst will be reported via an eDiary
- CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12 [ Time Frame: Baseline, Week 12 ]Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary
- CFB in weekly average of discomfort in the bladder at its worst at Week 12 [ Time Frame: Baseline, Week 12 ]Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary
- CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12 [ Time Frame: Baseline, Week 12 ]The GUPI assesses the degree of symptoms 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
- Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects [ Time Frame: Baseline, Week 12 ]Frequency of TEAEs occurring in ≥2% of subjects
- Overall frequency of TEAEs by severity grade [ Time Frame: Baseline, Week 12 ]Overall frequency of TEAEs by severity grade
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS
- Chronic bladder pain associated with filling the bladder over the past 6 months
- Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period
- Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency
- Body mass index (BMI) ≤40 kg/m2
- Willing to use a rectally administered product once daily for 12 weeks
Exclusion Criteria:
- Male subject has history of bacterial prostatitis or benign prostatic hyperplasia
- Has a condition that can be a contraindication to using a rectal foam
- Has cancer under active treatment or a history of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer
- Has a history of benign or malignant bladder tumors
- Has an active urinary tract infection or had ≥2 UTIs within the past 90 days
- Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years
- Has a malabsorption syndrome
- Had surgery in the pelvic or abdominal region within the past 90 days
- Has received a cystoscopy (with or without hydrodistension for reason other than pain relief) for diagnostic purposes within the past 30 days or a cystoscopy involving therapeutic hydrodistension (for pain relief) within the past 90 days
- Has history of pelvic irradiation or radiation cystitis
- Has a recent history of drug or alcohol abuse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05740007
Contact: Study Manager | 617-621-7722 | info@ironwoodpharma.com |
Study Director: | Medical Director | Ironwood Pharmaceuticals |
Responsible Party: | Ironwood Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT05740007 |
Other Study ID Numbers: |
C3300-201 |
First Posted: | February 22, 2023 Key Record Dates |
Last Update Posted: | May 2, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cystitis Cystitis, Interstitial Syndrome Somatoform Disorders Disease Pathologic Processes Mental Disorders |
Urinary Bladder Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |