Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin)… (NCT05737121) | Clinical Trial Compass
RecruitingPhase 2
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
United States120 participantsStarted 2023-05-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 th…
What they're measuring
1
Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12)