VNX001 for Interstitial Cystitis

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Vaneltix Pharma, Inc.

Must not be taking: Antidepressants, Narcotics, Marijuana, others

Disqualifiers: Pregnancy, Neurogenic bladder, CNS disorders, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests VNX001, a combination of heparin and lidocaine, to help patients with chronic bladder pain from IC/BPS. Heparin repairs the bladder lining, and lidocaine numbs the bladder to reduce pain. These treatments are commonly used to manage IC/BPS symptoms.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications before participating. You must not use local anesthetics within 48 hours, lidocaine patches within 14 days, pain medications within 6 hours, narcotics or medical marijuana within 3 weeks, and certain other drugs like tricyclic antidepressants unless on a stable dose. Check with the study team for specific guidance on your medications.

What data supports the effectiveness of the drug VNX001 for interstitial cystitis?

Research shows that a combination of heparin and alkalinized lidocaine can provide immediate relief from pain and urgency in patients with interstitial cystitis. In one case, a patient experienced significant improvement in symptoms and bladder capacity after receiving this treatment. ^{1 2 3 4 5}

Is the combination of heparin and alkalinized lidocaine safe for humans?

The combination of heparin and alkalinized lidocaine has been used in studies for interstitial cystitis and has shown to provide symptom relief without reported safety concerns in the provided research. ^{1 2 3 4 5}

How is the VNX001 treatment for interstitial cystitis different from other treatments?

VNX001 is unique because it combines heparin and alkalinized lidocaine, which are administered directly into the bladder (intravesical instillation) to provide immediate relief from pain and urgency associated with interstitial cystitis, unlike other treatments that may not offer such rapid symptom relief. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with moderate-to-severe bladder pain due to interstitial cystitis/bladder pain syndrome, lasting at least 9 months. Participants must have responded positively to previous anesthetic bladder treatments and not be allergic to heparin or lidocaine. Pregnant women, individuals with certain medical conditions, those on prohibited medications or who've had recent bladder procedures are excluded.

Inclusion Criteria

I may have had a bladder examination for my bladder pain.

My PUF questionnaire score is between 16 and 30.

I have had bladder pain for at least 9 months.

Exclusion Criteria

You have used ketamine in the past.

I have had bladder tumors before, whether cancerous or not.

I have heart issues or other conditions that could affect the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of VNX001, placebo, alkalinized lidocaine, or alkalinized heparin via intravesical instillation

Single dose

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 hours

Follow-up assessments at 6, 10, 12, 24, and 48 hours post-dose

Open-label extension (optional)

Participants may opt into receiving an additional single dose of VNX001

24-48 hours post-dose

Treatment Details

Interventions

• Lidocaine and Heparin (Local Anesthetic and Anticoagulant)
• Placebo (Other)
• VNX001 (Local Anesthetic and Anticoagulant)

Trial Overview The study tests VNX001's effectiveness in reducing bladder pain against its components (heparin and lidocaine) and a placebo. It's a Phase 2 trial where participants are randomly assigned to receive one of the treatments in a blinded manner, meaning neither they nor the researchers know which treatment they're getting.

Participant Groups

Group I: VNX001 Experimental Treatment 1 Intervention

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)

Group II: Lidocaine Experimental Treatment 1 Intervention

Lidocaine HCl (200 mg) in alkalinized buffer, administered as a single dose via intravesical instillation; n=45 (anticipated)

Group III: Heparin Experimental Treatment 1 Intervention

Heparin sodium (50,000 USPU) in alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)

Group IV: Placebo Placebo Group 1 Intervention

Alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)

Lidocaine and Heparin is already approved in United States, United States, European Union, European Union, Canada, Canada for the following indications:

🇺🇸 Approved in United States as Lidocaine Hydrochloride for:

• Local anesthesia
• Arrhythmias
• Pain relief

🇺🇸 Approved in United States as Heparin Sodium for:

• Anticoagulation
• Thrombosis prevention

🇪🇺 Approved in European Union as Lidocaine Hydrochloride for:

• Local anesthesia
• Arrhythmias
• Pain relief

🇪🇺 Approved in European Union as Heparin Sodium for:

• Anticoagulation
• Thrombosis prevention

🇨🇦 Approved in Canada as Lidocaine Hydrochloride for:

• Local anesthesia
• Arrhythmias
• Pain relief

🇨🇦 Approved in Canada as Heparin Sodium for:

• Anticoagulation
• Thrombosis prevention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Scripps Clinic Carmel Valley San Diego, CA

Florida Urology Partners Tampa, FL

University of California San Diego San Diego, CA

University of California Los Angeles Los Angeles, CA

More Trial Locations

Who Is Running the Clinical Trial?

Vaneltix Pharma, Inc. Lead Sponsor

Prevail Infoworks, Inc Collaborator

References

1. Canada pubmed.ncbi.nlm.nih.gov

Heparin and alkalinized lidocaine versus alkalinized lidocaine for treatment of interstitial cystitis symptoms. [2015] Interstitial cystitis (IC), sometimes referred to as IC/bladder pain syndrome, is a substantial health care problem. Once considered a rare, orphan disease, it is now believed to be relatively common. This pilot study was undertaken to determine if the combination of heparin and alkalinized lidocaine (heparin-lidocaine) was more efficacious than alkalinized lidocaine at relieving pain and urgency symptoms associated with IC and also capable of yielding higher lidocaine absorption.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. [2022] It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency, frequency, and pain associated with interstitial cystitis (IC). This combination has also been reported to relieve pain associated with sex in patients with IC.

3. Japan pubmed.ncbi.nlm.nih.gov

[Intravesical therapy of heparin and lidocaine for interstitial cystitis : a case report]. [2013] Interstitial cystitis (IC) is a chronic inflammatory condition of the urinary bladder, and its treatment has many uncertainties. We report a case of IC treated with intravesical instillation of heparin and alkalized lidocaine. A 64-year-old woman presented with urinary frequency and urgency with suprapubic pain. She underwent intravesical treatment with combined heparin and alkalinized lidocaine for IC, since prior medical treatments (imipramine, solifenacin, suplatast tosilate, and kampo extracts) and hydrodistention of bladder had little or no effect on her symptoms. A 50 ml solution containing 20,000 units of heparin, 200 mg of lidocaine and 7% sodium bicarbonate was administered intravesically twice a week for 12 months. The O'Leary-Sant IC symptom index score and IC problem index score improved from 20 to 8 and from 16 to 8, respectively, and her bladder capacity increased from 90 ml to 300 ml. Intravesical instillation of combined heparin and lidocaine was useful in the treatment of IC.

4. China pubmed.ncbi.nlm.nih.gov

[Treatment of intravesical instillation with fulguration-hydrodistention on female interstitial cystitis]. [2023] To investigate the efficacy and safety of intravesical instillation of heparin/alkalized lidocaine (lidocaine mixed with sodium bicarbonate) combined with hydrodistension and transurethral fulguration in the treatment of female interstitial cystitis (IC).

5. Australia pubmed.ncbi.nlm.nih.gov

On- and post-treatment symptom relief by repeated instillations of heparin and alkalized lidocaine in interstitial cystitis. [2022] To examine outcomes of intravesical instillations of heparin and alkalized lidocaine in patients with interstitial cystitis.