NCT06243614

Phase Ⅲ 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, Flexible-dose Phase Ⅲ Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (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 60-120 mg/ day of Buagafuran capsules in the treatment of GAD.

Detailed 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.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Buagafuran capsules, 15mg/ capsule	Participants took 60-120 mg Buagafuran capsules daily. The initial dose was 60mg/ day, 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;
DRUG	Buspirone tablets, 5mg/ tablet	Participants took 10-20mg Buspirone tablets daily. The initial dose was 10mg/ day, 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.
DRUG	Buagafuran capsules mimic, 0mg/ capsule	Participants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;
DRUG	Buspirone tablets mimic, 0mg/ tablet	Participants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.

Timeline

• Start date: 2023-07-24
• 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