Actively Recruiting
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
Led by Vaneltix Pharma, Inc. · Updated on 2026-01-22
120
Participants Needed
14
Research Sites
158 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 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.
CONDITIONS
Official Title
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be able and willing to give a signed informed consent and to follow study instructions
- Be male or female, 18 years of age or older
- Have a history of interstitial cystitis/bladder pain syndrome for at least 9 months prior to the study
- Have a score between 16 and 30 on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire 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 numeric rating scale at screening and 15 minutes post void immediately prior to study drug administration
- Have previously received a therapeutic intravesicular anesthetic treatment according to medication history
You will not qualify if you...
- 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 study
- Postmenopausal women on hormone replacement therapy not stabilized within 3 months of screening
- Known hypersensitivity to heparin or lidocaine
- Use of any local anesthetic by any route within 48 hours prior to study drug administration, or lidocaine patch or topical compounds within 14 days prior
- Use of tricyclic antidepressants or GABA analogues unless on a stable dose for at least 3 weeks (gabapentin max 1200 mg/day, pregabalin max 150 mg/day)
- Use of any pain medication within 6 hours prior to study drug administration
- Use of narcotics or medical marijuana within 3 weeks prior to study entry
- Use of prohibited drugs or influence of drugs affecting mentation that interfere with study or bias results
- Known abnormal laboratory test values deemed clinically significant
- Neurogenic bladder or disorders causing neurogenic bladder
- Pain or pain disorders making it difficult to discriminate bladder pain
- Severe central nervous system conditions impacting study participation
- History of arrhythmias, conduction disturbances, cardiac disease, or other significant coexisting medical condition
- Anesthetic bladder instillation therapy within 14 days prior to study entry
- In-office cystoscopy within 7 days of study drug administration
- Bladder dilatation (hydrodistension) within 3 months of study entry
- Evidence or suspicion of cancer detected during cystoscopy within 7 days prior or at screening
- Receipt of any investigational drug or device within 30 days prior to screening
- Current enrollment in another investigational drug or device study
- Unwillingness or inability to comply with study requirements
- Actively bleeding lesion or area in the bladder detected before randomization
- History of coagulopathy or current use of anticoagulants
- Use of medications inducing CYP1A2 and/or CYP3A4 such as phenytoin, carbamazepine, St. John's Wort, phenobarbital, rifampin
- Recent bacterial cystitis within 30 days
- 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 due to cyclophosphamide
- History or presence of urinary schistosomiasis
- Bladder or ureteral stones
- Clinically significant infectious vaginitis
- Currently uncontrolled genital herpes
- History or presence of urethral diverticulum
- Presence of bladder fistulae
- History of ketamine use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
IC Study LLC
Escondido, California, United States, 92025
Suspended
2
University of California Los Angeles Center for Women's Pelvic Health
Los Angeles, California, United States, 90095
Completed
3
The Clark Center for Urogynecology
Newport Beach, California, United States, 92663
Actively Recruiting
4
The Continence Center Medical Group, Inc dba Southern California Continence Center
Newport Beach, California, United States, 92663
Completed
5
University of California San Diego Medical Center
San Diego, California, United States, 92103
Actively Recruiting
6
Prestige Medical Group
Tustin, California, United States, 92780
Actively Recruiting
7
United Research Institute
Hialeah, Florida, United States, 33012
Actively Recruiting
8
Florida Urology Partners
Tampa, Florida, United States, 33615
Actively Recruiting
9
Georgia Urology
Cartersville, Georgia, United States, 30120
Actively Recruiting
10
Southern Clinical Research Associates LLC
Metairie, Louisiana, United States, 70001
Actively Recruiting
11
Bay State Clinical Trials
Watertown, Massachusetts, United States, 02472
Actively Recruiting
12
Sheldon Freedman MD LTD
Las Vegas, Nevada, United States, 89144
Actively Recruiting
13
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
14
The Wake Forest Institute of Regenerative Medicine
Winston-Salem, North Carolina, United States, 27101
Actively Recruiting
Research Team
V
Vaneltix Pharma, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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