Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Vaneltix Pharma, Inc.
Study ID
NCT06394830
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
    Intravesical administration of VNX001

Study Details

This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS). The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001. Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.

Key Dates

Start date
Dec 13, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label Arm
    VNX001 intravesical administration PRN up to 6 doses over 14 days. The VNX001 effective dose is 15 mL of buffered lidocaine HCl (200 mg) and sodium heparin (50,000 USPU).

Primary Outcome Measure

Frequency of PRN intravesical administrations of VNX001 [ Time Frame: 14 Days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Arizona Urology SpecialistsTucsonArizona85715-
Valley Urology, Inc.FresnoCalifornia93710-
Prestige Medical GroupTustinCalifornia92780-
Georgia UrologyCartersvilleGeorgia30120-
Oregon Urology InstituteSpringfieldOregon97477-

Find similar trials in Tucson, AZ

By research site
Arizona Urology Specialists· Tucson, AZValley Urology, Inc.· Fresno, CAPrestige Medical Group· Tustin, CAGeorgia Urology· Cartersville, GAOregon Urology Institute· Springfield, OR

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