Overactive Bladder Syndrome
Conditions
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.
Interventions
DRUGV117957
V117957 1 mg - 1 tablet taken orally at bedtime.
DRUGPlacebo
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Sponsors
Purdue Pharma LP
Imbrium Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Baseline, Weeks 2, and 8 | 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. |
Countries
United States
Participant flow
Recruitment details
This was a multi-center translational study conducted at study sites in the US.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 11.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 50 | 0 / 48 | 0 / 47 |
| other Total, other adverse events | 3 / 51 | 1 / 50 | 6 / 48 | 0 / 47 |
| serious Total, serious adverse events | 0 / 51 | 0 / 50 | 0 / 48 | 1 / 47 |
Outcome results
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.
Time frame: Baseline, Weeks 2, and 8
Population: The full analysis population is the group of subjects who were randomized, received study drug, and had at least 1 valid efficacy measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Week 2 (Placebo) | Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Number of Micturition Episodes per 24 hours | -0.8 Episodes per 24 hours | Standard Deviation 1.97 |
| Week 2 (Placebo) | Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Number of Incontinence Episodes per 24 hours | -0.2 Episodes per 24 hours | Standard Deviation 0.6 |
| Week 2 (Placebo) | Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Number of Urgency Episodes per 24 hours | -0.5 Episodes per 24 hours | Standard Deviation 1.2 |
| Week 8 (V117957) | Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Number of Micturition Episodes per 24 hours | -0.8 Episodes per 24 hours | Standard Deviation 2.32 |
| Week 8 (V117957) | Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Number of Incontinence Episodes per 24 hours | -0.4 Episodes per 24 hours | Standard Deviation 0.81 |
| Week 8 (V117957) | Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. | Number of Urgency Episodes per 24 hours | -0.5 Episodes per 24 hours | Standard Deviation 2.07 |