Phase 2 Study to Evaluate Safety and Effectiveness of VNX001 Compared to Lidocaine, Heparin, and Placebo for Reducing Bladder Pain in Adults With Interstitial CystitisBladder Pain Syndrome Experiencing Moderate to Severe Acute Bladder Pain

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination drug called VNX001 compared to placebo and its individual components, lidocaine hydrochloride and heparin sodium, in people with interstitial cystitisbladder pain syndrome ICBPS who are experiencing an episode of moderate to severe bladder pain. This Phase 2, multi-center, randomized, double-blind, placebo-controlled study aims to better understand how these treatments reduce bladder pain during acute episodes. Participants will be randomly assigned to receive a single dose of VNX001, placebo alkalinized phosphate buffer, alkalinized lidocaine, or alkalinized heparin. The treatments are administered through intravesical instillation directly into the bladder. After 24 to 48 hours, all participants have the option to receive a single open-label dose of VNX001. The randomization ratio is 3131 for VNX001, placebo, lidocaine, and heparin respectively. Throughout the study, participants will have their bladder pain intensity measured at various time points up to 24 hours after dosing using pain scales and questionnaires. Researchers will also monitor the use of the optional open-label VNX001 dose at 48 hours and track any adverse events for 72 hours. The total involvement includes screening, a single treatment visit, and follow-up assessments to evaluate pain relief and safety.

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS