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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 22, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Interstitial CystitisBladder Pain Syndrome
Interventions
DRUG

VNX001

VNX001 (alkalinized lidocaine HCl and heparin sodium)

DRUG

Placebo

Inactive placebo for VNX001

DRUG

Lidocaine

Alkalinized lidocaine hydrochloride

DRUG

Heparin

Alkalinized heparin sodium

Trial Locations (14)

11042

RECRUITING

Northwell Health, Lake Success

27101

RECRUITING

The Wake Forest Institute of Regenerative Medicine, Winston-Salem

30120

SUSPENDED

Georgia Urology, Cartersville

33012

RECRUITING

United Research Institute, Hialeah

33615

RECRUITING

Florida Urology Partners, Tampa

70001

RECRUITING

Southern Clinical Research Associates LLC, Metairie

89144

RECRUITING

Sheldon Freedman MD LTD, Las Vegas

90095

COMPLETED

University of California Los Angeles Center for Women's Pelvic Health, Los Angeles

92025

SUSPENDED

IC Study LLC, Escondido

92103

RECRUITING

University of California San Diego Medical Center, San Diego

92663

RECRUITING

The Clark Center for Urogynecology, Newport Beach

COMPLETED

The Continence Center Medical Group, Inc dba Southern California Continence Center, Newport Beach

92780

RECRUITING

Prestige Medical Group, Tustin

02472

RECRUITING

Bay State Clinical Trials, Watertown

All Listed Sponsors
collaborator

Prevail Infoworks

INDUSTRY

lead

Vaneltix Pharma, Inc.

INDUSTRY