Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06394830

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

Led by Vaneltix Pharma, Inc. · Updated on 2026-01-22

50

Participants Needed

5

Research Sites

76 weeks

Total Duration

On this page

Sponsors

V

Vaneltix Pharma, Inc.

Lead Sponsor

P

Prevail Infoworks

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Completed Study VNX001-111 if enrolling at sites conducting that study
  • Able and willing to give signed informed consent and follow study instructions
  • Male or female, 18 years or older
  • History of IC/BPS for at least 9 months, treated or untreated
  • Had a cystoscopy within 1 year of screening
  • PUF questionnaire score between 14 and 30 at screening
  • Experiencing an episode of moderate to severe acute bladder pain with a minimum pain score of 4 at screening and 15 minutes after voiding
Not Eligible

You will not qualify if you...

  • Female participants who are pregnant, lactating, or have a positive pregnancy test at screening
  • Females of child-bearing potential not using stable, medically acceptable birth control during the study
  • Males sexually active with females not willing to use acceptable birth control during the study
  • Postmenopausal women on hormone therapy not stabilized for at least 3 months
  • Known allergy to heparin or lidocaine
  • Use of local anesthetics other than intravesical instillation within 48 hours or lidocaine patches/topicals within 14 days before dosing
  • Use of tricyclic antidepressants or GABA analogues unless on a stable dose for at least 3 weeks with limits on gabapentin and pregabalin doses
  • Use of prohibited drugs or positive drug screen
  • Clinically significant abnormal lab results
  • Neurogenic bladder or related neurological disorders
  • Pain conditions making bladder pain assessment difficult
  • Severe central nervous system disorders impacting participation
  • History of heart rhythm problems or significant medical conditions affecting study
  • Recent bladder instillation therapy (within 14 days)
  • Recent cystoscopy (within 7 days)
  • Recent bladder dilation (within 3 months)
  • Evidence or suspicion of cancer during cystoscopy
  • Use of investigational drugs or devices within 30 days
  • Participation in other investigational studies
  • Inability or unwillingness to comply with study requirements
  • Active bladder bleeding unless deemed safe to continue
  • History of bleeding disorders or anticoagulant use
  • Use of phenytoin, carbamazepine, St. John's Wort, phenobarbital, or rifampin
  • Recent bacterial cystitis or history of pelvic irradiation or radiation cystitis
  • History or presence of certain cancers including uterine, cervical, pelvic, rectal, ovarian, vaginal, or bladder tumors
  • Current chemotherapy
  • History or presence of tuberculous or chemical cystitis
  • History or presence of urinary schistosomiasis
  • Bladder or ureteral stones
  • Significant infectious vaginitis or uncontrolled genital herpes
  • History or presence of urethral diverticulum or bladder fistulae
  • History of ketamine use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Arizona Urology Specialists

Tucson, Arizona, United States, 85715

Completed

2

Valley Urology, Inc.

Fresno, California, United States, 93710

Suspended

3

Prestige Medical Group

Tustin, California, United States, 92780

Suspended

4

Georgia Urology

Cartersville, Georgia, United States, 30120

Actively Recruiting

5

Oregon Urology Institute

Springfield, Oregon, United States, 97477

Actively Recruiting

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Research Team

V

Vaneltix Pharma, Inc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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