Clinical trial NCT06024642: Study of V117957 in Overactive Bladder Syndrome
Official title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder Syndrome
Lead sponsor: Imbrium Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Purdue Pharma LP
First posted: 2023-09-06
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.


Eligibility criteria: Key Inclusion Criteria include:

1. Female, age ≥18-70 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
2. Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months.
3. Willing to modify current OAB treatment regimen.

Key Exclusion Criteria include:

1. Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor.
2. Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI.
3. Hematuria associated with bladder malignancy or other significant pathology.
4. Had surgical procedure that affected bladder function.
5. Received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months.
6. Grade III/IV pelvic organ prolapse with/without cystocele or urethral diverticulum.
7. Clinically significant kidney disease or nephrolithiasis.

Other protocol-specific inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in number of micturition episodes per 24 hours and number of incontinence episodes per 24 hours.
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in volume voided per 24 hours.
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
Secondary outcomes:
measure: Change from baseline in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Subject Global Response Assessment (SGRA)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
measure: Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)
timeFrame: Baseline, Weeks 2, 4, 6, 8, and 9
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Urology Specialists, PLLC
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC
state: California
city: Long Beach
country: United States
facility: ARK Clinical Research
state: California
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Evergreen Park
country: United States
facility: Providea Health Partners, LLC
state: Illinois
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport - Regional Urology
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research-Lyndhurst
state: North Carolina
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
Study officials:
References: