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Compares treatment options for Interstitial Cystitis
Official title Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
ClinicalTrials.gov ID: NCT05737121
What this study is testing
What is VNX001?
VNX001 is an investigational medicine, being studied as a potential treatment for interstitial cystitis.
Also referred to as Alkalinized lidocaine HCl and heparin sodium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Have used a tricyclic antidepressant, or a gamma-aminobutyric acid (GABA) analogue (gabapentin or pregabalin), unless taking a stable dose of the...
See the full eligibility 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...
- Have previously received a therapeutic intravesicular anesthetic treatment according to medication history
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Escondido, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- San Diego, California, United States
- Tustin, California, United States
- Hialeah, Florida, United States
- Tampa, Florida, United States
- Cartersville, Georgia, United States
- Metairie, Louisiana, United States
- Watertown, Massachusetts, United States
- Las Vegas, Nevada, United States
- Lake Success, New York, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Escondido, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; San Diego, California, United States; Tustin, California, United States; Hialeah, Florida, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.