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RECRUITING
NCT07391306
PHASE2/PHASE3

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

Sponsor: 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.

Official title: 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)

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2024-02-16

Completion Date

2027-05-31

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Neovasculgen®

The bladder is hydro-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder.

DRUG

Placebo

The bladder is hydro-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder.

Locations (1)

Botkin Hospital

Moscow, Russia