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.
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…
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