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NCT05737121 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
A Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Vaneltix Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 14
- Study locations
NCT05737121: Recruiting Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Vaneltix Pharma.
NCT05737121 is a Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome that is actively recruiting participants, run by Vaneltix Pharma. The registered enrollment target is 120 participants, below the 358-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (66% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05737121, a Phase 2 study of Interstitial Cystitis and Bladder Pain Syndrome, is actively recruiting participants, sponsored by Vaneltix Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
A measure of the sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12), as determined using an 11-point numerical rating scale (NRS) for bladder pain. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lidocaine
- DRUG Heparin
- DRUG VNX001
Study Locations (14)
California
- IC Study LLC - Escondido
- University of California Los Angeles Center for Women's Pelvic Health - Los Angeles
- The Clark Center for Urogynecology - Newport Beach
- The Continence Center Medical Group, Inc dba Southern California Continence Center - Newport Beach
- University of California San Diego Medical Center - San Diego
- Prestige Medical Group - Tustin
Florida
- United Research Institute - Hialeah
- Florida Urology Partners - Tampa
Georgia
- Georgia Urology - Cartersville
Louisiana
- Southern Clinical Research Associates LLC - Metairie
Massachusetts
- Bay State Clinical Trials - Watertown
Nevada
- Sheldon Freedman MD LTD - Las Vegas
New York
- Northwell Health - Lake Success
North Carolina
- The Wake Forest Institute of Regenerative Medicine - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT05737121 shows while recruiting
NCT05737121 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 358-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Interstitial Cystitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05737121 lists 14 locations in 8 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT05737121 about?
NCT05737121 is a clinical study titled "Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS". 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 (HC...
What is the current status of trial NCT05737121?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-05-22. Estimated completion is 2026-06.
What conditions does trial NCT05737121 study?
This clinical trial studies the following conditions: Interstitial Cystitis, Bladder Pain Syndrome.
What interventions are being tested in trial NCT05737121?
The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG), Heparin (DRUG), VNX001 (DRUG).
Who is sponsoring clinical trial NCT05737121?
This trial is sponsored by Vaneltix Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05737121 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Interstitial Cystitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05737121's enrollment target sits among peer trials
120 10th of 26 higher than 17 of 26 other Interstitial Cystitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Cystitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
RECRUITING · Phase 2
-
Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)
RECRUITING · Phase 2
-
Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With IC
COMPLETED · Phase 2
-
Study of U101 for Bladder Pain and/or Urgency
COMPLETED · Phase 2
-
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
RECRUITING · NA
-
Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
RECRUITING · Phase 1
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