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

Part of paid clinical trials in Escondido, California.

Sponsor
Vaneltix Pharma, Inc.
Study ID
NCT05737121
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bladder Pain Syndrome
  • Interstitial Cystitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VNX001 — DRUG
    VNX001 (alkalinized lidocaine HCl and heparin sodium)
  • Placebo — DRUG
    Inactive placebo for VNX001
  • Lidocaine — DRUG
    Alkalinized lidocaine hydrochloride
  • Heparin — DRUG
    Alkalinized heparin sodium

Study Details

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.

Key Dates

Start date
May 22, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VNX001
    VNX001 (lidocaine HCl \[200 mg\] and heparin sodium \[50,000 USPU\] in alkalinized buffer), administered as a single dose via intravesical instillation; n=45 (anticipated)
  • Placebo Comparator: Placebo
    Alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)
  • Experimental: Lidocaine
    Lidocaine HCl (200 mg) in alkalinized buffer, administered as a single dose via intravesical instillation; n=45 (anticipated)
  • Experimental: Heparin
    Heparin sodium (50,000 USPU) in alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)

Primary Outcome Measure

Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12) [ Time Frame: 12 hours ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
IC Study LLCEscondidoCalifornia92025-
University of California Los Angeles Center for Women's Pelvic HealthLos AngelesCalifornia90095-
The Clark Center for UrogynecologyNewport BeachCalifornia92663-
The Continence Center Medical Group, Inc dba Southern California Continence CenterNewport BeachCalifornia92663-
University of California San Diego Medical CenterSan DiegoCalifornia92103-
Prestige Medical GroupTustinCalifornia92780-
United Research InstituteHialeahFlorida33012-
Florida Urology PartnersTampaFlorida33615-
Georgia UrologyCartersvilleGeorgia30120-
Southern Clinical Research Associates LLCMetairieLouisiana70001-
Bay State Clinical TrialsWatertownMassachusetts02472-
Sheldon Freedman MD LTDLas VegasNevada89144-
Northwell HealthLake SuccessNew York11042-
The Wake Forest Institute of Regenerative MedicineWinston-SalemNorth Carolina27101-

Find similar trials in Escondido, CA

By research site
IC Study LLC· Escondido, CAUniversity of California Los Angeles Center for Women's Pelvic Health· Los Angeles, CAThe Clark Center for Urogynecology· Newport Beach, CAThe Continence Center Medical Group, Inc dba Southern California Continence Center· Newport Beach, CAUniversity of California San Diego Medical Center· San Diego, CAPrestige Medical Group· Tustin, CA

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