drugset / Trial / NCT05737121
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2023-05-22
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Heparin | Other / unclassified | 50000 unknown | Other |
| Subject | Lidocaine | Other / unclassified | 200 mg | Other |
| Subject | VNX001 | Unknown | 200 mg | Other |
| Subject | VNX001 | Unknown | 50000 unknown | Other |