Trial Outcomes & Findings for Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome (NCT NCT06285214)
NCT ID: NCT06285214
Last Updated: 2026-03-09
Results Overview
Each evening and morning the subject responded to the question "Please indicate the worst bladder pain/discomfort you have had overnight/over-the-day" using an 11-point numerical rating scale (NRS) that ranges from 0 = "no bladder pain/discomfort" to 10 = "as bad as you can imagine bladder pain/discomfort."
COMPLETED
PHASE1
47 participants
Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.
2026-03-09
Participant Flow
Phase 1b multi-center translational study conducted 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), then Placebo for 2 weeks (double-blind period 1), then V117957 for 6 weeks (double-blind period 2) then placebo for 1 week (single-blind).
|
|---|---|
|
Single-blind Run-in Period
STARTED
|
47
|
|
Single-blind Run-in Period
COMPLETED
|
47
|
|
Single-blind Run-in Period
NOT COMPLETED
|
0
|
|
Double-blind / Safety Follow-up Phase
STARTED
|
46
|
|
Double-blind / Safety Follow-up Phase
COMPLETED
|
39
|
|
Double-blind / Safety Follow-up Phase
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome
Baseline characteristics by cohort
| Measure |
All Study Participants
n=46 Participants
Placebo for 2 weeks (single-blind), then Placebo for 2 weeks (double-blind period 1), then V117957 for 6 weeks (double-blind period 2) then placebo for 1 week (single-blind)
|
|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 11.95 • n=68 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.Population: The full analysis population is the group of subjects who were enrolled in the double-blind treatment period, received study drug, and had at least 1 valid efficacy measurement.
Each evening and morning the subject responded to the question "Please indicate the worst bladder pain/discomfort you have had overnight/over-the-day" using an 11-point numerical rating scale (NRS) that ranges from 0 = "no bladder pain/discomfort" to 10 = "as bad as you can imagine bladder pain/discomfort."
Outcome measures
| Measure |
Double-blind Treatment (Period 1)
n=45 Participants
Placebo for 2 weeks
|
Double-blind Treatment (Period 2)
n=39 Participants
V117957 for 6 weeks
|
|---|---|---|
|
Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day
Worst Pain Overnight
|
-0.7 score on a scale
Standard Deviation 1.41
|
-1.6 score on a scale
Standard Deviation 2.08
|
|
Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day
Worst Pain Over-the-Day
|
-0.8 score on a scale
Standard Deviation 1.52
|
-1.7 score on a scale
Standard Deviation 2.00
|
Adverse Events
Single-blind Run-in
Double-blind Treatment (Period 1)
Double-blind Treatment (Period 2)
Single-blind Follow-up
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single-blind Run-in
n=46 participants at risk
Placebo for 2 weeks.
|
Double-blind Treatment (Period 1)
n=46 participants at risk
Placebo for 2 weeks.
|
Double-blind Treatment (Period 2)
n=42 participants at risk
V117957 for 6 weeks.
|
Single-blind Follow-up
n=39 participants at risk
Placebo for 1 week.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
0.00%
0/46 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
7.1%
3/42 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
0.00%
0/39 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
|
Nervous system disorders
Somnolence
|
2.2%
1/46 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
4.3%
2/46 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
7.1%
3/42 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
0.00%
0/39 • Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 14 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 18 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER