Is NCT05737121 recruiting in Cartersville, GA?

Yes, NCT05737121 is currently recruiting participants at its Cartersville, GA location. This interstitial cystitis clinical trial is actively enrolling qualified participants.

How do I join the interstitial cystitis clinical trial in Cartersville?

To join this clinical trial in Cartersville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cartersville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Interstitial Cystitis Clinical Trial in Cartersville, GA

About This Interstitial Cystitis Study in Cartersville

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.

Sponsor: Vaneltix Pharma, Inc.

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cartersville?

Yes, this clinical trial (NCT05737121) has an active research site in Cartersville, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Interstitial Cystitis Treatment Options in Cartersville, GA

If you're searching for interstitial cystitis treatment options in Cartersville, GA, this clinical trial (NCT05737121) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cartersville research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced interstitial cystitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all interstitial cystitis clinical trials near you to find additional studies recruiting in your area.

Interstitial Cystitis Clinical Trial in Cartersville, GA

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