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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 4, 8, 12, and 24 hours
Awards & highlights
Study Summary
This trial will test a combination product to reduce bladder pain in IC/BPS patients compared to placebo and its components.
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.Check my eligibility
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.See study design
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 belowSelect...
My PUF questionnaire score is between 16 and 30.
Select...
I have had bladder pain for at least 9 months.
Select...
I experience moderate to severe bladder pain, scoring at least 5 out of 11.
Select...
I've had successful bladder pain treatments with medication.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)
Secondary outcome measures
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 moreTrial 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
Lidocaine
2011
Completed Phase 4
~1360
Heparin
2003
Completed Phase 4
~22600
Find a Location
Who is running the clinical trial?
Vaneltix Pharma, Inc.Lead Sponsor
Prevail Infoworks, IncUNKNOWN
1 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may have had a bladder examination for my bladder pain.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.I had a bladder examination with a scope within the last week.I have had bladder inflammation caused by chemicals or drugs.Cancer was found or suspected in my bladder recently.My PUF questionnaire score is between 16 and 30.I have had bladder pain for at least 9 months.I have active bleeding in my bladder confirmed by tests.I have had or currently have tuberculosis in my bladder.I experience moderate to severe bladder pain, scoring at least 5 out of 11.I had a bladder stretch procedure within the last 3 months.I am a postmenopausal woman not stable on hormone therapy for the last 3 months.I have a condition like Parkinson's or MS that affects my bladder control.I have taken pain medication within 6 hours before receiving the study drug.I have not used narcotics or medical marijuana in the last 3 weeks.I have had cancer in my uterus, cervix, pelvis, rectum, ovaries, or vagina.I had bladder treatment recently or it didn't work with heparin and lidocaine.I have kidney stones in my bladder or ureter.I am a man who will not use birth control during the study.You are allergic to heparin or lidocaine.I am not pregnant, nor am I breastfeeding.I am not taking medications like Phenytoin, Carbamazepine, or St. John's Wort.I have had or currently have a urinary tract infection caused by parasites.I haven't used any local anesthetic or lidocaine products recently.I have been on a stable dose of certain nerve pain medications for over 3 weeks.You have a lab test result that the doctor thinks is a big concern.I have pain that makes it hard to tell apart from bladder-related pelvic pain.I am currently undergoing chemotherapy.I am 18 years old or older.I have or had a urethral diverticulum.I have an abnormal connection between my bladder and another organ.I had a urinary tract infection with a high bacteria count in the last month.I have had radiation treatment in my pelvic area.You have a severe mental health condition that may affect your ability to follow the study rules or affect the study results.I've had successful bladder pain treatments with medication.I have a severe vaginal infection.I have genital herpes that is not currently under control.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Heparin
- Group 2: Lidocaine
- Group 3: VNX001
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical facilities are currently running this research study?
"Six medical centres are currently participating in this trial, including Prestige Medical Group in Santa Ana and Georgia Urology in Cartersville. Other sites include Southern Clinical Research Associates LLC located in Metairie."
Answered by AI
Has the FDA given its stamp of approval to VNX001?
"There is data suggesting VNX001's safety, leading to the score of 2 on the 1-3 scale. At this stage in its development, there is yet to be any clinical evidence proving efficacy for VNX001."
Answered by AI
Are there any open opportunities for individuals to participate in this research?
"Clinicaltrials.gov reveals that this medical trial, which initially went live on March 7th 2023 and was last reviewed on February 22nd of the same year, is no longer actively recruiting patients. However, there are 1441 other active clinical studies currently enrolling participants."
Answered by AI
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