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NCT05737121 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Vaneltix Pharma.

Recruiting
Registry status
Phase 2
Development phase
120
Enrollment target
14
Study locations

NCT05737121 is a Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome that is actively recruiting participants, run by Vaneltix Pharma. The registered enrollment target is 120 participants, below the 358-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (66% lower). The trial reports 14 study locations across 8 states.

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The verdict

NCT05737121, a Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome, is actively recruiting participants, sponsored by Vaneltix Pharma.

RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
14
Study locations

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

Interstitial Cystitis Bladder Pain Syndrome

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

FieldValue
Enrollment Target 120 participants
Start Date 2023-05-22
Est. Completion 2026-06
Phase Phase 2

Sponsor

Vaneltix Pharma

2 total trials

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What the Registry Record Tells You About NCT05737121

The ClinicalTrials.gov registry entry for NCT05737121 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 358-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (66% lower). The listed sponsor is Vaneltix Pharma, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT05737121 reports 14 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Georgia.

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.

What interventions are being tested in trial NCT05737121?

The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG), Heparin (DRUG), VNX001 (DRUG).

Who is sponsoring clinical trial NCT05737121?

This trial is sponsored by Vaneltix Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.