Study of VNX001 for Interstitial Cystitis/Bladder Pain Syndrome
This study is testing a new combination medicine called VNX001 (alkalinized lidocaine HCl and heparin sodium) for people with interstitial cystitis (IC) / bladder pain syndrome (BPS) who are experiencing moderate to severe bladder pain. Researchers want to see if VNX001 is safe and effective at reducing bladder pain compared to a placebo (an inactive substance) or its individual ingredients, lidocaine or heparin. To join, you must be at least 18 years old, have had IC/BPS for at least 9 months, and have a certain score on a pain questionnaire. The main goal is to measure how much your bladder pain intensity changes 12 hours after receiving the study treatment. The study aims to enroll 120 participants, but the current recruitment status is unclear.
- Study design
- This is a Phase 2, randomized, double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctor will know which treatment you receive. It involves about 120 participants receiving a single dose of the study medicine.
- What's involved
- You would receive a single dose of VNX001, placebo, lidocaine, or heparin. You will be asked about your bladder pain intensity 12 hours after the dose. You may also have the option to request a single dose of VNX001 24-48 hours after your initial dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary pain measurement is taken 12 hours after the dose. You may also have the option for an additional dose 24-48 hours post-dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05737121
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
Recruiting
PHASE2Ages 18+InterventionalTreatmentVaneltix Pharma, Inc.
~120 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:VNX001PlaceboLidocaineHeparin
At a glance
Recruiting sites
11 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)
Measured over 12 hours
Conditions
Where it's being run
14 sites across 8 statesCalifornia6
Florida2
Georgia1
Louisiana1
Massachusetts1
Nevada1
New York1
North Carolina1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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 stabilized on a regimen of hormone replacement therapy within 3 months of screening
Have a known hypersensitivity to heparin or lidocaine
Have used any local anesthetic by any route within 48-hours prior to study drug administration, or used a lidocaine patch or lidocaine containing topical compounds within 14 days prior to study drug administration
Have used a tricyclic antidepressant, or a gamma-aminobutyric acid (GABA) analogue (gabapentin or pregabalin), unless taking a stable dose of the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day
Have used any pain medication within 6 hours prior to study drug administration
Have used narcotics or medical marijuana ≤ 3 weeks prior to study entry
Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results
Have a known abnormal laboratory test value that, in the investigator's judgement, is clinically significant.
Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage)
Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain
Have any of the following central nervous system (CNS) conditions that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results, severe diagnosed: major depressive disorder, bipolar disorder, schizophrenia, general anxiety disorder, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder
Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results
Had anesthetic bladder instillation therapy within 14 days prior to study entry
Had an in-office cystoscopy within 7 days of study drug administration
Had dilatation (hydrodistension) of bladder within 3 months of study entry
Evidence or suspected presence of cancer detected during cystoscopy 7 days prior to or at time of initial screening
Has received any investigational drug or device within 30 days prior to screening
Is currently enrolled in another investigational drug or device study
Is unwilling or unable to abide by the requirements of the study
Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization
Have a history of coagulopathy or taking anticoagulants.
Are taking any of the following medications, which are inducers of CYP1A2 and/or CYP3A4: Phenytoin, Carbamazepine, St. John's Wort, Phenobarbital, Rifampin
Have had any of the following:
Bacterial cystitis within 30 days as demonstrated by a positive urine culture (≥ 105 bacteria per mL)
History of pelvic irradiation or radiation cystitis
History or presence of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer
History of benign or malignant bladder tumors
Current chemotherapy
History or presence of tuberculous cystitis
History or presence of chemical cystitis, including that due to cyclophosphamide
History or presence of urinary schistosomiasis
Bladder or ureteral calculi
Clinically significant infectious vaginitis
Currently uncontrolled genital herpes
History or presence of urethral diverticulum
Presence of bladder fistulae
History of ketamine use
What this trial measures
- Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)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.