Clinical Trial

Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.
Trial Details
NCT Number NCT07391878
Lead Sponsor Trigone Pharma Ltd.
Conditions Overactive Bladder (OAB)
Enrollment 60 participants
Start Date 2026-02-15
Primary Completion 2027-12-15 (estimated)
Study Completion 2027-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-02-06