What side effects are associated with this type of intervention?

Common treatments for Interstitial Cystitis, such as the combination of Heparin Sodium and Lidocaine Hydrochloride, have specific side effects. Heparin can cause bleeding, bruising, and rarely, a decrease in platelets (heparin-induced thrombocytopenia). Lidocaine may lead to localized irritation, allergic reactions, and systemic effects like dizziness or cardiac issues if absorbed in large amounts. When administered intravesically, these treatments may reduce systemic side effects but can still cause local irritation or discomfort.

What prior FDA approvals exist?

The FDA has approved several treatments for Interstitial Cystitis (IC), focusing on symptom relief and bladder protection. Pentosan polysulfate sodium (Elmiron) is the only oral medication specifically approved for IC, which works by forming a protective layer on the bladder wall. Intravesical therapies, which involve directly instilling medications into the bladder, have also been used. These include combinations of heparin and lidocaine, which provide anti-inflammatory and anesthetic effects, respectively. While specific FDA approvals for heparin and lidocaine combinations are not detailed, these treatments are commonly used off-label to manage IC symptoms.

What other types of research exist?

Promising novel alternatives to VNX001 for Interstitial Cystitis patients include: 1) Tolvaptan, which has shown a decrease in kidney pain and may have potential for bladder pain management; 2) Catheter-based renal denervation, which targets pain signals and has shown encouraging results in pain reduction; 3) Alpha(2)-adrenergic agonists like Clonidine, which have potent analgesic properties and can be used in pain management protocols. These alternatives should be discussed with a healthcare provider to evaluate their suitability and potential benefits for individual patients.

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Local Anesthetic and Anticoagulant

VNX001 for Interstitial Cystitis

Phase 2

Recruiting

Research Sponsored by Vaneltix Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a score of ≥ 16 and ≤ 30 on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire, completed at screening

Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study

Must not have

History of benign or malignant bladder tumors

Had an in-office cystoscopy within 7 days of study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 4, 8, 12, and 24 hours

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to heparin or lidocaine such as bleeding issues, allergic responses, local numbness or irritation at the site of administration. Systemic side effects could involve changes in heart rhythm or blood pressure if absorbed into circulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PUF questionnaire score is between 16 and 30.

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I have had bladder pain for at least 9 months.

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I experience moderate to severe bladder pain, scoring at least 5 out of 11.

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I've had successful bladder pain treatments with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I had a bladder examination with a scope within the last week.

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I have had bladder inflammation caused by chemicals or drugs.

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I have active bleeding in my bladder confirmed by tests.

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I have had or currently have tuberculosis in my bladder.

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I have taken pain medication within 6 hours before receiving the study drug.

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I have had cancer in my uterus, cervix, pelvis, rectum, ovaries, or vagina.

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I had bladder treatment recently or it didn't work with heparin and lidocaine.

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I have kidney stones in my bladder or ureter.

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I am a man who will not use birth control during the study.

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I am not pregnant, nor am I breastfeeding.

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I am not taking medications like Phenytoin, Carbamazepine, or St. John's Wort.

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I have had or currently have a urinary tract infection caused by parasites.

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I am currently undergoing chemotherapy.

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I have or had a urethral diverticulum.

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I have an abnormal connection between my bladder and another organ.

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I had a urinary tract infection with a high bacteria count in the last month.

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I have had radiation treatment in my pelvic area.

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I have a severe vaginal infection.

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I have genital herpes that is not currently under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 4, 8, 12, and 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 4, 8, 12, and 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 4, 8, 12, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)

Secondary study objectives

Adverse events (AEs)

Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) questionnaire

Change in bladder pain from baseline to 1, 4, 8, 12, and 24 hours post-dose

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: VNX001Experimental Treatment1 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: LidocaineExperimental Treatment1 Intervention

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

Group III: HeparinExperimental Treatment1 Intervention

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

Group IV: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Heparin

2003

Completed Phase 4

~22600

Lidocaine

2011

Completed Phase 4

~1370

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Interstitial Cystitis (IC) include intravesical therapies, oral medications, and surgical interventions. Intravesical therapies, such as the combination of Heparin Sodium and Lidocaine Hydrochloride, are particularly relevant. Heparin acts as an anti-inflammatory and anticoagulant, helping to repair the bladder lining and reduce inflammation. Lidocaine is a local anesthetic that blocks nerve signals, providing pain relief. These mechanisms are crucial for IC patients as they target both the inflammation and pain associated with the condition, offering symptomatic relief and improving quality of life.

Lidocaine prevents noxious excitation of bladder afferents induced by intravesical capsaicin without interfering with the ensuing sensory desensitization: an experimental study in the rat.