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.
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
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
Vaneltix Pharma, Inc.
Lead sponsor
Prevail Infoworks
Collaborator