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| Name | Class |
|---|---|
| Purdue Pharma LP | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V117957 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V117957 | Drug | V117957 1 mg - 1 tablet taken orally at bedtime. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day | Each evening and morning the subject responded to the question "Please indicate the worst bladder pain/discomfort you have had overnight/over-the-day" using an 11-point numerical rating scale (NRS) that ranges from 0 = "no bladder pain/discomfort" to 10 = "as bad as you can imagine bladder pain/discomfort." | Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported. |
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Key Inclusion Criteria include:
Key Exclusion Criteria include:
Other protocol-specific inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama, PC | Homewood | Alabama | 35209 | United States | ||
| Urological Associates of Southern Arizona |
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This was a two-period single-sequence crossover design with investigative sites and subjects blinded to both the randomization eligibility criteria and the assignment of subjects to only a single treatment sequence (placebo followed by active). The study included a single-blind run-in phase (2-week placebo exposure); a double-blind treatment phase (2-weeks placebo immediately followed by 6-weeks V117957 exposure); and a safety follow-up phase (2 weeks duration).
Phase 1b multi-center translational study conducted in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Placebo for 2 weeks (single-blind), then Placebo for 2 weeks (double-blind period 1), then V117957 for 6 weeks (double-blind period 2) then placebo for 1 week (single-blind). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Single-blind Run-in Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2024 |
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| Placebo |
| Drug |
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime. |
|
| Tucson |
| Arizona |
| 85715 |
| United States |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | United States |
| Investigational Site | Escondido | California | 92025 | United States |
| Urology Group of Southern California | Los Angeles | California | 90017 | United States |
| Hope Clinical Research, LLC | Los Angeles | California | 91303 | United States |
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | United States |
| Accel Research Sites | DeLand | Florida | 32720 | United States |
| Accel Research Site - Neurostudies | Decatur | Georgia | 30033 | United States |
| Providea Health Partners LLC | Evergreen Park | Illinois | 60805 | United States |
| Otrimed Clinical Research | Edgewood | Kentucky | 41017 | United States |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | United States |
| Ochsner Louisiana State University Health Shreveport - Regional University | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology Research Associates | Owings Mills | Maryland | 21117 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | United States |
| Revive Research Institute, Inc | Dearborn Heights | Michigan | 48127 | United States |
| CentraCare - Urology Clinic | Sartell | Minnesota | 56377 | United States |
| Adult & Pediatric Urology P.C. | Omaha | Nebraska | 68114 | United States |
| AccuMed Research Associates | Garden City | New York | 11530 | United States |
| Manhattan Medical Research Practice | New York | New York | 10016 | United States |
| Unified Women's Clinical Research-Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| MetroHealth System | Cleveland | Ohio | 44109 | United States |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Double-blind / Safety Follow-up Phase |
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The group of subjects who received at least 1 dose of study drug during double-blind treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Placebo for 2 weeks (single-blind), then Placebo for 2 weeks (double-blind period 1), then V117957 for 6 weeks (double-blind period 2) then placebo for 1 week (single-blind) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day | Each evening and morning the subject responded to the question "Please indicate the worst bladder pain/discomfort you have had overnight/over-the-day" using an 11-point numerical rating scale (NRS) that ranges from 0 = "no bladder pain/discomfort" to 10 = "as bad as you can imagine bladder pain/discomfort." | The full analysis population is the group of subjects who were enrolled in the double-blind treatment period, received study drug, and had at least 1 valid efficacy measurement. | Posted | Mean | Standard Deviation | score on a scale | Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported. |
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Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 18 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-blind Run-in | Placebo for 2 weeks. | 0 | 46 | 0 | 46 | 2 | 46 |
| EG001 | Double-blind Treatment (Period 1) | Placebo for 2 weeks. | 0 | 46 | 0 | 46 | 2 | 46 |
| EG002 | Double-blind Treatment (Period 2) | V117957 for 6 weeks. | 0 | 42 | 0 | 42 | 6 | 42 |
| EG003 | Single-blind Follow-up | Placebo for 1 week. | 0 | 39 | 0 | 39 | 0 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Imbrium Therapeutics L.P. | 1-888-827-0622 | Medinfo@imbriumthera.com |
| Jan 26, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Worst Pain Over-the-Day |
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