This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, multi-center, single-dose, pharmacodynamic study designed to evaluate the efficacy and safety of the combination product (VNX001) versus placebo and its individual components (heparin sodium and lidocaine hydrochloride (HCl)) for the reduction of bladder pain in patients with interstitial cystitis (IC) / bladder pain syndrome (BPS), Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity.
This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, multi-center, single-dose, pharmacodynamic study designed to evaluate the efficacy and safety of the combination product (VNX001) versus placebo and its individual components (heparin sodium and lidocaine hydrochloride) for the reduction of bladder pain in patients with IC/BPS, Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity. The study will enroll a target of 120 subjects, with a maximum of 180 subjects, across approximately 12 sites in the United States. Each study subject will receive a single dose of VNX001, placebo (alkalinized phosphate buffer), alkalinized lidocaine, or alkalinized heparin by random assignment. The randomization ratio will be 3:1:3:1, respectively. At 24-48-hours post-dose, all subjects will be given the option of requesting a single dose of VNX001.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
IC Study LLC
Escondido, California, United States
SUSPENDEDUniversity of California Los Angeles Center for Women's Pelvic Health
Los Angeles, California, United States
COMPLETEDThe Clark Center for Urogynecology
Newport Beach, California, United States
RECRUITINGThe Continence Center Medical Group, Inc dba Southern California Continence Center
Newport Beach, California, United States
COMPLETEDUniversity of California San Diego Medical Center
San Diego, California, United States
RECRUITINGPrestige Medical Group
Tustin, California, United States
RECRUITINGUnited Research Institute
Hialeah, Florida, United States
RECRUITINGFlorida Urology Partners
Tampa, Florida, United States
RECRUITINGGeorgia Urology
Cartersville, Georgia, United States
RECRUITINGSouthern Clinical Research Associates LLC
Metairie, Louisiana, United States
RECRUITING...and 4 more locations
Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)
A measure of the sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12), 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.
Time frame: 12 hours
Sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively)
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.
Time frame: 6, 10, or 24 hours
Change in bladder pain from baseline to 1, 4, 8, 12, and 24 hours post-dose
Average absolute change and average percentage change in bladder pain from baseline to 1, 4, 8, 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.
Time frame: 1, 4, 8, 12, and 24 hours
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire
Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 1, 10, and 24 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects 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).
Time frame: 1, 10, and 24 hours
Use of optional open-label intravesical administration of VNX001
Number of patients requesting the optional open-label intravesical administration of VNX001 at 24-48 hours after randomized study drug administration
Time frame: 48 hours
Adverse events (AEs)
Incidence of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and discontinuations due to AEs
Time frame: 72 hours
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