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

Recruiting Phase 2 Interventional Study
Interstitial Cystitis Bladder Pain Syndrome
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Vaneltix Pharma, Inc. · Industry
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About This Trial
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 syn…
Trial Locations
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Eligibility Criteria
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) ques…
Contacts

Vaneltix Pharma, Inc.

732-354-3217

info@vaneltix.com

CONTACT