Trial Outcomes & Findings for Study of V117957 in Overactive Bladder Syndrome (NCT NCT06024642)
NCT ID: NCT06024642
Last Updated: 2025-06-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Baseline, Weeks 2, and 8
Results posted on
2025-06-26
Participant Flow
This was a multi-center translational study conducted at study sites in the US.
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).
Participant milestones
| Measure |
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).
|
|---|---|
|
Single-blind Run-in Period
STARTED
|
51
|
|
Single-blind Run-in Period
COMPLETED
|
51
|
|
Single-blind Run-in Period
NOT COMPLETED
|
0
|
|
Double-blind / Safety Follow-up Phase
STARTED
|
51
|
|
Double-blind / Safety Follow-up Phase
COMPLETED
|
47
|
|
Double-blind / Safety Follow-up Phase
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of V117957 in Overactive Bladder Syndrome
Baseline characteristics by cohort
| Measure |
All Study Participants
n=50 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).
|
|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 2, and 8Population: The full analysis population is the group of subjects who were randomized, received study drug, and had at least 1 valid efficacy measurement.
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.
Outcome measures
| Measure |
Week 2 (Placebo)
n=47 Participants
Placebo for 2 weeks.
|
Week 8 (V117957)
n=44 Participants
V117957 for 6 weeks.
|
|---|---|---|
|
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
|
-0.8 Episodes per 24 hours
Standard Deviation 2.32
|
|
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 0.60
|
-0.4 Episodes per 24 hours
Standard Deviation 0.81
|
|
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 1.20
|
-0.5 Episodes per 24 hours
Standard Deviation 2.07
|
Adverse Events
Single-blind Run-in Period (Placebo)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Double-blind Treatment Phase (Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Double-blind Treatment Phase (V117957)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Safety Follow-up Phase (Placebo)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-blind Run-in Period (Placebo)
n=51 participants at risk
Placebo for 2 weeks.
|
Double-blind Treatment Phase (Placebo)
n=50 participants at risk
Placebo for 2 weeks.
|
Double-blind Treatment Phase (V117957)
n=48 participants at risk
V117957 for 6 weeks.
|
Safety Follow-up Phase (Placebo)
n=47 participants at risk
Placebo for 1 week.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/51 • 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).
|
0.00%
0/50 • 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).
|
0.00%
0/48 • 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).
|
2.1%
1/47 • 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).
|
Other adverse events
| Measure |
Single-blind Run-in Period (Placebo)
n=51 participants at risk
Placebo for 2 weeks.
|
Double-blind Treatment Phase (Placebo)
n=50 participants at risk
Placebo for 2 weeks.
|
Double-blind Treatment Phase (V117957)
n=48 participants at risk
V117957 for 6 weeks.
|
Safety Follow-up Phase (Placebo)
n=47 participants at risk
Placebo for 1 week.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • 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).
|
2.0%
1/50 • 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).
|
12.5%
6/48 • 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).
|
0.00%
0/47 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60