Vaneltix Pharma, Inc.
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 si…
Inclusion Criteria: * Be able and willing to give a signed informed consent and to follow study instructions * Be male or female, ≥ 18 years of age * Have a history of IC/BPS for at least 9 months prior to the study * Have a score of ≥ 16 and ≤ 30 on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire, completed at screening * Have an episode of acute bladder pain of moderate to severe intensity with a minimum score of 5 on the 11-point bladder pain NRS at time of screening and 15 minutes post void immediately prior to study drug administration. * Have previously received a therapeutic…
VNX001 (alkalinized lidocaine HCl and heparin sodium)
Inactive placebo for VNX001
Alkalinized lidocaine hydrochloride
Alkalinized heparin sodium