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

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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 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 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