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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 22, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site details revised at 1 of 14 sitesv15
  2. Primary and study completion dates: Dec 2025 to Jun 2026v14
  3. Study sites: 13 to 14
    • Eligibility criteria shortened, about 16 words
    v13
  4. Site details revised at 1 of 13 sitesv12
  5. Study sites: 11 to 13v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary and study completion dates: May 22, 2025 to Dec 2025v10
  2. Site details revised at 1 of 11 sites
    • Eligibility criteria shortened, about 2 words
    v9
  3. Site details revised at 3 of 11 sitesv8
  4. Site details revised at 1 of 11 sitesv7
  5. Primary and study completion dates: May 22, 2024 to May 22, 2025
    • Study sites: 8 to 11
    • Eligibility criteria shortened, about 21 words
    • Study description expanded, about 13 words
    v6
  6. Study sites: 10 to 8v5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 10
    • Primary and study completion dates: Mar 1, 2024 to May 22, 2024
    • Start date changed from estimate of Mar 7, 2023 to May 22, 2023
    v4
  8. Study sites: 6 to 8v3
  9. Study sites: 1 to 6
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (5)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05737121
Lead Sponsor Vaneltix Pharma, Inc.
Collaborators: Prevail Infoworks
Conditions
(from sponsor)		 Interstitial Cystitis, Bladder Pain Syndrome
Related terms Cystitis, Interstitial
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov