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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 overactive bladder 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 in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Subjects were asked to record all micturition episode components into a daily electronic diary during the 3 to 7 days prior to each scheduled clinic visit. | Baseline, Weeks 2, and 8 |
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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 |
|---|---|---|---|---|---|---|
| Arizona Urology Specialists, PLLC | Tucson | Arizona | 85715 | United States | ||
| Hope Clinical Research, LLC |
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).
This was a multi-center translational study conducted at study sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Placebo for 2 weeks (single-blind run-in), then placebo for 2 weeks immediately followed by V117957 for 6 weeks (double-blind treatment phase) then placebo for 1 week (safety follow-up phase). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single-blind Run-in Period |
| |||||||||||||
| Double-blind / Safety Follow-up Phase |
|
The group of subjects who were randomized and received at least 1 dose of study drug during the double-blind treatment phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Placebo for 2 weeks (single-blind run-in), then placebo for 2 weeks immediately followed by V117957 for 6 weeks (double-blind treatment phase) then placebo for 1 week (safety follow-up phase). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Subjects were asked to record all micturition episode components into a daily electronic diary during the 3 to 7 days prior to each scheduled clinic visit. | The full analysis population is the group of subjects who were randomized, received study drug, and had at least 1 valid efficacy measurement. | Posted | Mean | Standard Deviation | Episodes per 24 hours | Baseline, Weeks 2, and 8 |
|
Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 16 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 20 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 Period (Placebo) | Placebo for 2 weeks. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | 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 |
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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 | Aug 25, 2023 | May 20, 2025 | Prot_SAP_000.pdf |
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| Placebo | Drug | Placebo to match V117957 tablets - 1 tablet taken orally at bedtime. |
|
| Canoga Park |
| California |
| 91303 |
| United States |
| ARK Clinical Research | Long Beach | California | 90815 | United States |
| Urology Group of Southern California | Los Angeles | California | 90017 | United States |
| Providea Health Partners, LLC | Evergreen Park | Illinois | 60805 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Ochsner LSU Health Shreveport - Regional Urology | Shreveport | Louisiana | 71106 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | United States |
| AccuMed Research Associates | Garden City | New York | 11530 | United States |
| Unified Women's Clinical Research-Lyndhurst | Winston-Salem | North Carolina | 27103 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 51 |
| 0 |
| 51 |
| 3 |
| 51 |
| EG001 | Double-blind Treatment Phase (Placebo) | Placebo for 2 weeks. | 0 | 50 | 0 | 50 | 1 | 50 |
| EG002 | Double-blind Treatment Phase (V117957) | V117957 for 6 weeks. | 0 | 48 | 0 | 48 | 6 | 48 |
| EG003 | Safety Follow-up Phase (Placebo) | Placebo for 1 week. | 0 | 47 | 1 | 47 | 0 | 47 |
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