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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
IC Study LLC
SUSPENDED
Escondido
University of California Los Angeles Center for Women's Pelvic Health
COMPLETED
Los Angeles
The Clark Center for Urogynecology
RECRUITING
Newport Beach
The Continence Center Medical Group, Inc dba Southern California Continence Center
COMPLETED
Newport Beach
University of California San Diego Medical Center
RECRUITING
San Diego
Prestige Medical Group
RECRUITING
Tustin
Florida
United Research Institute
RECRUITING
Hialeah
Florida Urology Partners
RECRUITING
Tampa
Georgia
Georgia Urology
SUSPENDED
Cartersville
Louisiana
Southern Clinical Research Associates LLC
RECRUITING
Metairie
Massachusetts
Bay State Clinical Trials
RECRUITING
Watertown
North Carolina
The Wake Forest Institute of Regenerative Medicine
RECRUITING
Winston-salem
Nevada
Sheldon Freedman MD LTD
RECRUITING
Las Vegas
New York
Northwell Health
RECRUITING
Lake Success
Contact Information
Primary
Vaneltix Pharma, Inc.
info@vaneltix.com
732-354-3217
Time Frame
Start Date:2023-05-22
Estimated Completion Date:2025-12
Participants
Target number of participants:120
Treatments
Experimental: VNX001
VNX001 (lidocaine HCl \[200 mg\] and heparin sodium \[50,000 USPU\] in alkalinized buffer), administered as a single dose via intravesical instillation; n=45 (anticipated)
Placebo_comparator: Placebo
Alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)
Experimental: Lidocaine
Lidocaine HCl (200 mg) in alkalinized buffer, administered as a single dose via intravesical instillation; n=45 (anticipated)
Experimental: Heparin
Heparin sodium (50,000 USPU) in alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)