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New bladder pain cocktail aims to ease Flare-Ups fast

NCT ID NCT05737121

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single dose of VNX001, a mix of lidocaine and heparin, to quickly reduce moderate to severe bladder pain in people with interstitial cystitis/bladder pain syndrome. About 120 adults with a history of IC/BPS for at least 9 months will receive either VNX001, placebo, or one of its components alone. The main goal is to see how well the combination relieves pain over 12 hours.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Bay State Clinical Trials

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Florida Urology Partners

    RECRUITING

    Tampa, Florida, 33615, United States

  • Georgia Urology

    RECRUITING

    Cartersville, Georgia, 30120, United States

  • IC Study LLC

    SUSPENDED

    Escondido, California, 92025, United States

  • Northwell Health

    RECRUITING

    Lake Success, New York, 11042, United States

  • Prestige Medical Group

    RECRUITING

    Tustin, California, 92780, United States

  • Sheldon Freedman MD LTD

    RECRUITING

    Las Vegas, Nevada, 89144, United States

  • Southern Clinical Research Associates LLC

    RECRUITING

    Metairie, Louisiana, 70001, United States

  • The Clark Center for Urogynecology

    RECRUITING

    Newport Beach, California, 92663, United States

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

    COMPLETED

    Newport Beach, California, 92663, United States

  • The Wake Forest Institute of Regenerative Medicine

    RECRUITING

    Winston-Salem, North Carolina, 27101, United States

  • United Research Institute

    RECRUITING

    Hialeah, Florida, 33012, United States

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

    COMPLETED

    Los Angeles, California, 90095, United States

  • University of California San Diego Medical Center

    RECRUITING

    San Diego, California, 92103, United States

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