Interstitial Cystitis/Bladder Pain SyndromePhase 1NCT06285214

Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome

A Phase 1 study testing V117957 in people with Interstitial Cystitis/Bladder Pain Syndrome, run by Imbrium Therapeutics at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Interstitial Cystitis/Bladder Pain Syndrome
What is being tested?: V117957
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 24 sitesUnited States
Study dates: 26 May 2022to 28 Jan 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes".
Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9.
Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility.

Who cannot join

Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator.
Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI.
Hematuria determined to be associated with bladder malignancy or other significant pathology.
Had surgical procedure at any time that affected bladder function.
Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology.
Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.
Other protocol-specific inclusion and exclusion criteria may apply.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Boston Clinical Trials
Boston, Massachusetts, 02131
MetroHealth System
Cleveland, Ohio, 44109
Revive Research Institute, Inc
Dearborn Heights, Michigan, 48127
Accel Research Site - Neurostudies
Decatur, Georgia, 30033
Accel Research Sites
DeLand, Florida, 32720
Otrimed Clinical Research
Edgewood, Kentucky, 41017
Investigational Site
Escondido, California, 92025
Providea Health Partners LLC
Evergreen Park, Illinois, 60805
AccuMed Research Associates
Garden City, New York, 11530
Urology Centers of Alabama, PC
Homewood, Alabama, 35209
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Urology Group of Southern California
Los Angeles, California, 90017
Hope Clinical Research, LLC
Los Angeles, California, 91303
Southern Clinical Research Associates
Metairie, Louisiana, 70001
Tri Valley Urology Medical Group
Murrieta, California, 92562
Manhattan Medical Research Practice
New York, New York, 10016
Adult & Pediatric Urology P.C.
Omaha, Nebraska, 68114
Chesapeake Urology Research Associates
Owings Mills, Maryland, 21117
CentraCare - Urology Clinic
Sartell, Minnesota, 56377
Ochsner Louisiana State University Health Shreveport - Regional University
Shreveport, Louisiana, 71106
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Unified Women's Clinical Research-Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome

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

Conditions: Interstitial Cystitis/Bladder Pain Syndrome
Being tested: V117957, Placebo
Medical subject headings: Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V117957Drug
V117957 1 mg - 1 tablet taken orally at bedtime.
PlaceboDrug
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Study groups in NCT06285214
Study group	Role	What they receive
V117957	Experimental	Not described Receives: Drug: V117957
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day
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."
Measured: Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 202228 Jan 2025

First posted29 Feb 2024
Study start26 May 2022
Primary completion28 Jan 2025
Study completion28 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Interstitial Cystitis/Bladder Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06285214
Sponsor's protocol ID: OAG1050
Status last verified: Feb 2026
First submitted: 22 Feb 2024
Last updated: 9 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome

All Interstitial Cystitis/Bladder Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome
ClinicalTrials.gov ID: NCT06285214
Acronym / sponsor ID: OAG1050
Conditions: Interstitial Cystitis/Bladder Pain Syndrome
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Imbrium TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Purdue Pharma LP
Study start: 26 May 2022 (actual)
Primary completion: 28 Jan 2025 (actual)
Study completion: 28 Jan 2025 (actual)
First posted: 29 Feb 2024 (actual)
Results: Posted 9 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
V117957	Experimental	Drug: V117957
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes".
Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9.
Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility.

Key exclusion criteria (7 listed)

Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator.
Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI.
Hematuria determined to be associated with bladder malignancy or other significant pathology.
Had surgical procedure at any time that affected bladder function.
Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V117957V117957 1 mg - 1 tablet taken orally at bedtime.	Drug	V117957
PlaceboPlacebo to match V117957 tablets - 1 tablet taken orally at bedtime.	Drug	Placebo

Primary outcome

Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day
Time frame: Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.
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."

Results and safety

Results posted to the registry on 9 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	47	47

Primary outcome: Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day

Time frame: Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.. Mean (Standard Deviation). Unit: score on a scale

Measure	Double-blind Treatment (Period 1) n = 45	Double-blind Treatment (Period 2) n = 39
Worst Pain Overnight	-0.7 (1.41)	-1.6 (2.08)
Worst Pain Over-the-Day	-0.8 (1.52)	-1.7 (2.00)

Population analysed: 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.

Adverse events

Time frame: 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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-blind Run-in	0 of 46 (0%)	2 of 46 (4.3%)	0 of 46
Double-blind Treatment (Period 1)	0 of 46 (0%)	2 of 46 (4.3%)	0 of 46
Double-blind Treatment (Period 2)	0 of 42 (0%)	6 of 42 (14.3%)	0 of 42
Single-blind Follow-up	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Interstitial Cystitis/Bladder Pain Syndrome

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V117957 in people with Interstitial Cystitis/Bladder Pain Syndrome, run by Imbrium Therapeutics at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day (time frame: Assessed at Baseline, Weeks 2 and 8. Change from Baseline to Week 2 (Period 1) and Week 8 (Period 2) reported.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06285214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.