RECRUITING

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS

Conditions

Interstitial Cystitis Bladder Pain Syndrome interstitial cystitis (IC)bladder pain syndrome (BPS)alkalinized lidocaine heparin intravesical VNX001

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 (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.

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

Quick Facts

Study Start:2023-05-22

Study Completion:2025-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05737121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 received a cystoscopy in association with their diagnosis of IC/BPS within 1 year of screening. * 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 with positive response, therapeutic intravesicular anesthetic treatments according to medication history	* 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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 received a cystoscopy in association with their diagnosis of IC/BPS within 1 year of screening.
* 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 with positive response, therapeutic intravesicular anesthetic treatments according to medication history

* 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
* 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

Contacts and Locations

Study Contact

Vaneltix Pharma, Inc.

CONTACT

732-354-3217

info@vaneltix.com

Study Locations (Sites)

IC Study LLC

Escondido, California, 92025

United States

University of California Los Angeles Center for Women's Pelvic Health

Los Angeles, California, 90095

United States

The Continence Center Medical Group, Inc dba Southern California Continence Center

Newport Beach, California, 92663

United States

University of California San Diego Medical Center

San Diego, California, 92103

United States

Prestige Medical Group

Santa Ana, California, 92705

United States

United Research Institute

Hialeah, Florida, 33012

United States

Florida Urology Partners

Tampa, Florida, 33615

United States

Georgia Urology

Cartersville, Georgia, 30120

United States

Southern Clinical Research Associates LLC

Metairie, Louisiana, 70001

United States

Sheldon Freedman MD LTD

Las Vegas, Nevada, 89144

United States

Northwell Health

Lake Success, New York, 11042

United States

Collaborators and Investigators

Sponsor: Vaneltix Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-22

Study Completion Date2025-05-22

Study Record Updates

Study Start Date2023-05-22

Study Completion Date2025-05-22

Terms related to this study

Keywords Provided by Researchers

interstitial cystitis (IC)
bladder pain syndrome (BPS)
alkalinized lidocaine
heparin
intravesical
VNX001

Additional Relevant MeSH Terms

Interstitial Cystitis
Bladder Pain Syndrome