Bladder Pain Syndrome, Interstitial Cystitis
Conditions
Keywords
interstitial cystitis (IC), bladder pain syndrome (BPS), alkalinized lidocaine, heparin, intravesical, VNX001
Brief summary
This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS). The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001. Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.
Interventions
DRUGVNX001
Intravesical administration of VNX001
Sponsors
Vaneltix Pharma, Inc.
Prevail Infoworks
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Enrolled and completed Study VNX001-111 (i.e., at any site that is concurrently conducting the VNX001-111 study, a subject must have previously enrolled and completed Study VNX001-111 to be eligible for entry into the VNX001-110 study) and meet all other inclusion/
Exclusion criteria
. 2. Be able and willing to give a signed informed consent and to follow study instructions. 3. Be male or female, ≥ 18 years of age. 4. Have a history of IC/BPS for at least 9 months prior to the study, either treated (e.g. Elmiron®, RIMSO-50®), or untreated. 5. Have received a cystoscopy in association with their diagnosis of IC/BPS within 1 year of screening. 6. Have a score of ≥ 14 and ≤ 30 on the PUF questionnaire, completed at screening. 7. Have an episode of acute bladder pain of moderate to severe intensity with a minimum score of 4 on the 11-point bladder pain NRS at time of screening and 15 minutes post void immediately prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of PRN intravesical administrations of VNX001 | 14 Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bladder pain from first dose baseline to 1, 2, 6, 12, and 24 hours post-dose | Through 24 Hours | Average absolute change and average percentage change in bladder pain from baseline to 1, 2, 6, 12, and 24 hours post-dose, as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain. |
| Change in bladder pain after each repeat dose to 1, 6, 12, and 24 hours post-dose | Through 24 Hours | Average absolute change and average percentage change in bladder pain from after each repeat dose to 1, 6, 12, and 24 hours post-dose, as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain. |
| Sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively) | Through 24 Hours | A measure of the sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively), as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain. |
| Change in the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire | Through 24 Hours | Change in percentage of subjects achieving ≥ 50% improvement in pain, urgency and overall improvement using the PORIS questionnaire at 1, 12, and 24 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. Subjects will be asked to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement). |
| Pain scale threshold associated with subjects seeking repeat dosing | 14 Days | The average NRS pain assessment threshold before each PRN repeat intravesical VNX001 treatment. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain. |
| Adverse events (AEs) | up to 17 Days | Incidence of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and discontinuations due to AEs through the last follow up call at 48-72 hours after the last clinic or telephone visit. |
Countries
United States
Contacts
CONTACTVaneltix Pharma, Inc.
Outcome results
None listed