Study of V117957 in Overactive Bladder Syndrome

Imbrium Therapeutics

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder Syndrome

Treatments: Drug: Placebo; Drug: V117957

Study type: Interventional

Funder types: Industry

Identifiers

NCT06024642

OAG1030

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

V117957

Experimental group

Treatment:

Drug: V117957

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo