Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
NCT05737121 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lidocaine
- DRUG Heparin
- DRUG VNX001
Study Locations (14)
California
- IC Study LLC — Escondido
- University of California Los Angeles Center for Women's Pelvic Health — Los Angeles
- The Clark Center for Urogynecology — Newport Beach
- The Continence Center Medical Group, Inc dba Southern California Continence Center — Newport Beach
- University of California San Diego Medical Center — San Diego
- Prestige Medical Group — Tustin
Florida
- United Research Institute — Hialeah
- Florida Urology Partners — Tampa
Georgia
- Georgia Urology — Cartersville
Louisiana
- Southern Clinical Research Associates LLC — Metairie
Massachusetts
- Bay State Clinical Trials — Watertown
Nevada
- Sheldon Freedman MD LTD — Las Vegas
New York
- Northwell Health — Lake Success
North Carolina
- The Wake Forest Institute of Regenerative Medicine — Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05737121
The ClinicalTrials.gov registry entry for NCT05737121 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaneltix Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Interstitial Cystitis appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05737121 reports 14 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05737121 about?
NCT05737121 is a clinical study titled "Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS". 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 (HC...
What is the current status of trial NCT05737121?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-05-22. Estimated completion is 2026-06.
What conditions does trial NCT05737121 study?
This clinical trial studies the following conditions: Interstitial Cystitis, Bladder Pain Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05737121?
The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG), Heparin (DRUG), VNX001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05737121?
This trial is sponsored by Vaneltix Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05737121 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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