NCT05737121 · Vaneltix Pharma, Inc.
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
What this study is about
This is a Phase 2, forward-looking, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, multi-center, single-dose, how the drug affects the body study designed to evaluate the effectiveness 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.
View original scientific description
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.
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
Primary outcome measures
Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)
Time frame: 12 hours
A measure of the sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12), as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be able and willing to give a signed informed consent and to follow study instructions
- Be male or female, ≥ 18 years of age
- Have a history of IC/BPS for at least 9 months prior to the study
- Have a score of ≥ 16 and ≤ 30 on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire, completed at screening
- Have an episode of acute bladder pain of moderate to severe intensity with a minimum score of 5 on the 11-point bladder pain NRS at time of screening and 15 minutes post void immediately prior to study drug administration.
- Have previously received a therapeutic intravesicular anesthetic treatment according to medication history
Exclusion criteria
- For females, have a positive pregnancy test at screening or be pregnant or lactating
- Males who are sexually active with females and are not willing to commit to an acceptable method of birth control for the duration of the
- Postmenopausal women who, if taking hormone replacement therapy, have not been st
Where
- Escondido, California
- Los Angeles, California
- Newport Beach, California
- San Diego, California
- Tustin, California
- Hialeah, Florida
- Tampa, Florida
- Cartersville, Georgia
- Metairie, Louisiana
- Watertown, Massachusetts
- Las Vegas, Nevada
- Lake Success, New York
And 1 more location — see the full list below.
Collaborators
Prevail Infoworks
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2026 · Source of record for eligibility and locations