Interstitial CystitisPhase 2NCT05737121
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
A Phase 2 study testing VNX001, Lidocaine and Heparin in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Vaneltix Pharma, Inc. at 14 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- VNX001, Lidocaine and Heparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 14 sitesUnited States
- Study dates
- 22 May 2023to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 11 recruiting
- Recruiting
Georgia Urology
Cartersville, Georgia, 30120
- Suspended
IC Study LLC
Escondido, California, 92025
- Recruiting
United Research Institute
Hialeah, Florida, 33012
- Recruiting
Northwell Health
Lake Success, New York, 11042
- Recruiting
Sheldon Freedman MD LTD
Las Vegas, Nevada, 89144
- Completed
University of California Los Angeles Center for Women's Pelvic Health
Los Angeles, California, 90095
- Recruiting
Southern Clinical Research Associates LLC
Metairie, Louisiana, 70001
- Recruiting
The Clark Center for Urogynecology
Newport Beach, California, 92663
- Completed
The Continence Center Medical Group, Inc dba Southern California Continence Center
Newport Beach, California, 92663
- Recruiting
University of California San Diego Medical Center
San Diego, California, 92103
- Recruiting
Florida Urology Partners
Tampa, Florida, 33615
- Recruiting
Prestige Medical Group
Tustin, California, 92780
- Recruiting
Bay State Clinical Trials
Watertown, Massachusetts, 02472
- Recruiting
The Wake Forest Institute of Regenerative Medicine
Winston-Salem, North Carolina, 27101
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of VNX001 Compared to Placebo, and the Individual Components of Lidocaine, and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity; The Engage 2024 Study
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.
Read the detailed 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) for the reduction of bladder pain in patients with IC/BPS, Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity. The study will enroll a target of 120 subjects, with a maximum of 180 subjects, across approximately 12 sites in the United States. Each study subject will receive a single dose of VNX001, placebo (alkalinized phosphate buffer), alkalinized lidocaine, or alkalinized heparin by random assignment. The randomization ratio will be 3:1:3:1, respectively. At 24-48-hours post-dose, all subjects will be given the option of requesting a single dose of VNX001.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- VNX001, Placebo, Lidocaine, Heparin
- Keywords
- interstitial cystitis (IC), bladder pain syndrome (BPS), alkalinized lidocaine, heparin, intravesical, VNX001
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNX001Drug
Also called Alkalinized lidocaine HCl and heparin sodium
VNX001 (alkalinized lidocaine HCl and heparin sodium)
PlaceboDrug
Also called Placebo (for VNX001)
Inactive placebo for VNX001
LidocaineDrug
Also called Alkalinized lidocaine HCl
Alkalinized lidocaine hydrochloride
HeparinDrug
Also called Alkalinized heparin sodium
Alkalinized heparin sodium
| Study group | Role | What they receive |
|---|---|---|
| VNX001 | Experimental | 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) Receives: Drug: VNX001 |
| Placebo | Placebo comparator | Alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated) Receives: Drug: Placebo |
| Lidocaine | Experimental | Lidocaine HCl (200 mg) in alkalinized buffer, administered as a single dose via intravesical instillation; n=45 (anticipated) Receives: Drug: Lidocaine |
| Heparin | Experimental | Heparin sodium (50,000 USPU) in alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated) Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)
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.
Measured: 12 hours
Secondary outcomes (5)
Sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively)
A measure of the sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively), 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.
Measured: 6, 10, or 24 hours
Change in bladder pain from baseline to 1, 4, 8, 12, and 24 hours post-dose
Average absolute change and average percentage change in bladder pain from baseline to 1, 4, 8, 12, and 24 hours post-dose, 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.
Measured: 1, 4, 8, 12, and 24 hours
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire
Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 1, 10, and 24 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement).
Measured: 1, 10, and 24 hours
Use of optional open-label intravesical administration of VNX001
Number of patients requesting the optional open-label intravesical administration of VNX001 at 24-48 hours after randomized study drug administration
Measured: 48 hours
Adverse events (AEs)
Incidence of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and discontinuations due to AEs
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start22 May 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- IC/BPS patients will be randomly assigned to receive a single dose of one of the following treatments in a ratio of 3:1:3:1: * 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaneltix Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prevail Infoworks
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737121
- Sponsor's protocol ID
- VNX001-111; Engage 2024
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of VNX001 Compared to Placebo, and the Individual Components of Lidocaine, and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity; The Engage 2024 Study
- ClinicalTrials.gov ID
- NCT05737121
- Acronym / sponsor ID
- VNX001-111; Engage 2024
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- interstitial cystitis (IC), bladder pain syndrome (BPS), alkalinized lidocaine, heparin, intravesical, VNX001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vaneltix Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prevail Infoworks
- Study start
- 22 May 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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) for the reduction of bladder pain in patients with IC/BPS, Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity. The study will enroll a target of 120 subjects, with a maximum of 180 subjects, across approximately 12 sites in the United States. Each study subject will receive a single dose of VNX001, placebo (alkalinized phosphate buffer), alkalinized lidocaine, or alkalinized heparin by random assignment. The randomization ratio will be 3:1:3:1, respectively. At 24-48-hours post-dose, all subjects will be given the option of requesting a single dose of VNX001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- IC/BPS patients will be randomly assigned to receive a single dose of one of the following treatments in a ratio of 3:1:3:1: * 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.
| Arm | Type | Receives |
|---|---|---|
| VNX001 | Experimental | Drug: VNX001VNX001 (lidocaine HCl [200 mg] and heparin sodium [50,000 USPU] in alkalinized buffer), administered as a single dose via intravesical instillation; n=45 (anticipated) |
| Placebo | Placebo comparator | Drug: PlaceboAlkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated) |
| Lidocaine | Experimental | Drug: LidocaineLidocaine HCl (200 mg) in alkalinized buffer, administered as a single dose via intravesical instillation; n=45 (anticipated) |
| Heparin | Experimental | Drug: HeparinHeparin sodium (50,000 USPU) in alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNX001Also: Alkalinized lidocaine HCl and heparin sodiumVNX001 (alkalinized lidocaine HCl and heparin sodium) | Drug | VNX001 |
| PlaceboAlso: Placebo (for VNX001)Inactive placebo for VNX001 | Drug | Placebo |
| LidocaineAlso: Alkalinized lidocaine HClAlkalinized lidocaine hydrochloride | Drug | Lidocaine |
| HeparinAlso: Alkalinized heparin sodiumAlkalinized heparin sodium | Drug | Heparin |
Primary outcome
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.
5 secondary outcomes
Sum of bladder pain intensity differences from baseline to 6, 10, and 24 hours post-dose (SPID-6, SPID-10, and SPID-24, respectively)
Time frame: 6, 10, or 24 hours
Change in bladder pain from baseline to 1, 4, 8, 12, and 24 hours post-dose
Time frame: 1, 4, 8, 12, and 24 hours
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire
Time frame: 1, 10, and 24 hours
Use of optional open-label intravesical administration of VNX001
Time frame: 48 hours
Adverse events (AEs)
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- ENGAGE2024 Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VNX001, Lidocaine and Heparin in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Vaneltix Pharma, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vaneltix Pharma, Inc. (732-354-3217, info@vaneltix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12) (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.