A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of VNX001 Compared to Placebo, and the Individual Components of Lidocaine, and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity; The Engage 2024 Study

Vaneltix Pharma, Inc.

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.

Description

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) for the reduction of bladder pain in patients with IC/BPS, Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity. The study will enroll a target of 120 subjects, with a maximum of 180 subjects, across approximately 12 sites in the United States. Each study subject will receive a si…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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) 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…

Interventions

Drug
VNX001
VNX001 (alkalinized lidocaine HCl and heparin sodium)
Drug
Placebo
Inactive placebo for VNX001
Drug
Lidocaine
Alkalinized lidocaine hydrochloride
Drug
Heparin
Alkalinized heparin sodium

Locations (14)

IC Study LLC
Escondido, California
University of California Los Angeles Center for Women's Pelvic Health
Los Angeles, California
The Clark Center for Urogynecology
Newport Beach, California
The Continence Center Medical Group, Inc dba Southern California Continence Center
Newport Beach, California
University of California San Diego Medical Center
San Diego, California
Prestige Medical Group
Tustin, California