Interstitial Cystitis/Bladder Pain Syndrome
Conditions
Brief 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.
Interventions
DRUGV117957
V117957 1 mg - 1 tablet taken orally at bedtime.
DRUGPlacebo
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Sponsors
Imbrium Therapeutics
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria include: 1. Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception. 2. 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". 3. 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. 4. 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
include: 1. Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator. 2. Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI. 3. Hematuria determined to be associated with bladder malignancy or other significant pathology. 4. Had surgical procedure at any time that affected bladder function. 5. 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. 6. Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis. Other protocol-specific inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Worst Bladder Pain/Discomfort Scores Overnight / Over-the-day | 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." |
Countries
United States
Participant flow
Recruitment details
Phase 1b multi-center translational study conducted 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).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 39 Participants |
| Sex: Female, Male Female | 46 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 / 46 | 0 / 46 | 0 / 42 | 0 / 39 |
| other Total, other adverse events | 2 / 46 | 2 / 46 | 6 / 42 | 0 / 39 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 | 0 / 42 | 0 / 39 |
Outcome results
None listed