Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)
Public ClinicalTrials.gov record NCT06394830. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Open Label, Single-Arm, Multi-Center, Multiple Dose, 14-Day Study to Evaluate the Safety, Efficacy, and Frequency of Intravesical Administration of VNX001 in Acute Treatment of Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS). The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001. Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.
Study identification
- NCT ID
- NCT06394830
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2024
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
- Last update posted
- Jan 21, 2026
2024 – 2026
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Urology Specialists | Tucson | Arizona | 85715 | Completed |
| Valley Urology, Inc. | Fresno | California | 93710 | Suspended |
| Prestige Medical Group | Tustin | California | 92780 | Suspended |
| Georgia Urology | Cartersville | Georgia | 30120 | Recruiting |
| Oregon Urology Institute | Springfield | Oregon | 97477 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06394830, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06394830 live on ClinicalTrials.gov.