Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS (NCT05737121)
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
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: IC Study LLC — Escondido, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- 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
- United Research Institute — Hialeah, Florida
- Florida Urology Partners — Tampa, Florida
- Georgia Urology — Cartersville, Georgia
- Southern Clinical Research Associates LLC — Metairie, Louisiana
- Bay State Clinical Trials — Watertown, Massachusetts
- Sheldon Freedman MD LTD — Las Vegas, Nevada
- Northwell Health — Lake Success, New York
- The Wake Forest Institute of Regenerative Medicine — Winston-Salem, North Carolina
📞 Contact the Study Coordinator
Phone: (732) 354-3217
Email: info@vaneltix.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Interstitial Cystitis
- Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome — Los Angeles, California
- A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management — Houston, Texas
- Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis — Winston-Salem, North Carolina
- Investigation of PEMF Therapy for Female Patients With IC/BPS — Winston-Salem, North Carolina
- Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome — Louisville, Kentucky
Explore by condition: All Interstitial Cystitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.