Loading clinical trials...

The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions. | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions.

Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome/Interstitial Cystitis (BPS/IC)

NCT07391306•JSC NextGen

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.

Eligibility

Age

18 - 65 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent prior to any study-related procedures.
•2. Women aged 18 to 65 years, inclusive.
•3. A confirmed diagnosis of painful bladder syndrome/interstitial cystitis, characterized by pelvic pain associated with filling or emptying the bladder, frequent urination day and night, with symptoms lasting at least 12 months, with the exclusion of a urinary tract infection or other disease that could cause such symptoms.
•4. Absence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
•5. A glycated hemoglobin level within the normal range for the patient's age group.
•6. Ability to comply with all study requirements, at the discretion of the investigator, including regularly keeping a voiding diary, completing questionnaires, and attending all scheduled study visits.
•7. Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.

Exclusion Criteria

•1. Any condition that prevents intravesical administration of medications.
•2. Received medication or non-medication therapy, including physical therapy, for BPS/IC within 1 month prior to study inclusion.
•3. Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.
•4. History of chronic drug or alcohol abuse.
•5. Pregnant women, planning to become pregnant during the study, or currently breastfeeding.
•6. Any other conditions associated with pelvic pain, except for BPS
•7. Pelvic surgery less than 6 months prior to the study
•8. Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening
•9. History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.
•10. Inability to discontinue anticoagulant/antiplatelet medications at least 5 days prior to each investigational drug administration and resume them on the 4th day after each investigational drug administration (low molecular weight heparin may be used for 3 days after investigational drug administration).
+5 more criteria

Locations (1)

Botkin Hospital

Moscow, Russia

Key Dates

Start Date

February 16, 2024

Primary Completion Date

May 31, 2027

Completion Date

May 31, 2027

Last Updated

February 5, 2026

Enrollment

180

ESTIMATED participants

Conditions

ICInterstitial Cystitis and Bladder Pain SyndromeInterstitial Cystitis, Chronic

Interventions

Neovasculgen®

DRUG

Placebo

DRUG

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452

Clostridium DifficileClostridium Difficile Infections+8 more

View study

RECRUITINGPHASE2

Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)

NCT06311214

Advanced Malignant Solid NeoplasmMetastatic Malignant Solid Neoplasm

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions.

Inclusion Criteria

Exclusion Criteria

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)

Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma