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Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD — BGFN-2022-01  

Generalized Anxiety Disorder Clinical Trial

Official title:
Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Flexible-dose Phase Ⅲ Clinical Trial

Clinical Trial Summary

A placebo-controlled superiority design was used to evaluate the efficacy of 60-120 mg/ day of Buagafuran capsules in the treatment of GAD.

Clinical Trial Description

This was a multi-center, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, flexible-dose phase III clinical trial of Buagafuran capsules. The stratification factor was the presence or absence of new generalized anxiety disorder (GAD) (new GAD vs. Non-new GAD). Qualified subjects, according to the ratio of 2:2:1, were randomized into experimental group, placebo-control group and positive-control group, and received a treatment course of 8 weeks. Participants were followed from baseline outpatient visit until end of the follow-up period( 10 weeks and 7 visits in total). The dose of Buagafuran capsules/ Buagafuran capsules mimic can be adjusted from 60mg/ day to 120mg/ day according to treatment needs and tolerance in the follow-up period( at week 1, week 2, and week 4), and the dose of Buspirone tablets/ Buspirone tablets mimic can be adjusted from 10mg/ day to 20mg/ day at the same time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06243614
Study type Interventional
Source Beijing Union Pharmaceutical Factory Ltd
Contact Tao Sun
Phone 13621169498
Email sunny.suntao@aliyun.com
Status Recruiting
Phase Phase 3
Start date July 24, 2023
Completion date June 30, 2027
View Details
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