NCT05357677

To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Assess the Efficacy, Safety, and Tolerability of SR419 in Patients With Postherpetic Neuralgia (PHN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects.

Detailed description

The study will evaluate the efficacy and safety of SR419 in PHN patients. Each subject will participate in the study for up to approximately 14 weeks. This includes a screening period, drug treatment period, and post-treatment safety follow-up period. This is a crossover design study, in which subjects will be administered with SR419 and placebo according to their randomized sequence, that is, eligible subjects will be randomized in a 1:1 ratio to 1 of 2 double-blind treatment sequences: 30 mg of SR419 administered TID followed by placebo administered TID or placebo administered TID followed by 30 mg of SR419 administered TID.

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	SR419	SR419 capsule

Timeline

• Start date: 2022-05-13
• Primary completion: 2023-01-13
• Completion: 2023-01-18
• First posted: 2022-05-03
• Last updated: 2024-01-05

Locations

13 sites across 2 countries: Australia, China