Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
NCT ID: NCT05737121
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2023-05-22
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* VNX001 (n=45): alkalinized buffered lidocaine HCl (200 mg) and heparin sodium (50,000 USPU), administered as an intravesical instillation
* Placebo (n=15): alkalinized buffer, administered as an intravesical instillation
* Lidocaine (n=45): alkalinized buffered lidocaine HCl (200 mg), administered as an intravesical instillation
* Heparin (n=15): alkalinized buffered heparin sodium (50,000 USPU), administered as an intravesical instillation
* At 24-48-hours post-dose, all subjects will be given the option of requesting a single open-label dose of VNX001.
TREATMENT
DOUBLE
Study Groups
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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)
VNX001
VNX001 (alkalinized lidocaine HCl and heparin sodium)
Placebo
Alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)
Placebo
Inactive placebo for VNX001
Lidocaine
Lidocaine HCl (200 mg) in alkalinized buffer, administered as a single dose via intravesical instillation; n=45 (anticipated)
Lidocaine
Alkalinized lidocaine hydrochloride
Heparin
Heparin sodium (50,000 USPU) in alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)
Heparin
Alkalinized heparin sodium
Interventions
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VNX001
VNX001 (alkalinized lidocaine HCl and heparin sodium)
Placebo
Inactive placebo for VNX001
Lidocaine
Alkalinized lidocaine hydrochloride
Heparin
Alkalinized heparin sodium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Prevail Infoworks
INDUSTRY
Vaneltix Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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IC Study LLC
Escondido, California, United States
University of California Los Angeles Center for Women's Pelvic Health
Los Angeles, California, United States
The Clark Center for Urogynecology
Newport Beach, California, United States
The Continence Center Medical Group, Inc dba Southern California Continence Center
Newport Beach, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Prestige Medical Group
Tustin, California, United States
United Research Institute
Hialeah, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Georgia Urology
Cartersville, Georgia, United States
Southern Clinical Research Associates LLC
Metairie, Louisiana, United States
Bay State Clinical Trials
Watertown, Massachusetts, United States
Sheldon Freedman MD LTD
Las Vegas, Nevada, United States
Northwell Health
Lake Success, New York, United States
The Wake Forest Institute of Regenerative Medicine
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Related Links
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ENGAGE2024 Study Website
Other Identifiers
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VNX001-111; Engage 2024
Identifier Type: -
Identifier Source: org_study_id
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