NCT06243640

Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD

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, Fixed-dose Phase Ⅲ Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Beijing Union Pharmaceutical Factory Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This was a multi-center, randomized, double-blind, placebo-controlled, fixed-dose phase III clinical trial. Hierarchical factors for whether new generalized anxiety disorder (GAD) (new GAD vs. Non-new GAD). Qualified subjects, according to the ratio of 1:1:1, were randomized into high-dose group, low-dose group and placebo-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).

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Buagafuran capsules, 15mg/ capsule	Subjects took Buagafuran capsules; twice per day, respectively, after breakfast and dinner for 8 weeks;
DRUG	Buagafuran capsules mimic, 0mg/ capsule	Subjects took Buagafuran capsules mimic. twice per day, respectively, after breakfast and dinner for 8 weeks;

Timeline

• Start date: 2023-07-25
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2024-02-06
• Last updated: 2024-02-06

Locations

1 site across 1 country: China