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RECRUITING
NCT06243614
PHASE3

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

Sponsor: Beijing Union Pharmaceutical Factory Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2023-07-24

Completion Date

2027-06-30

Last Updated

2024-02-06

Healthy Volunteers

No

Interventions

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.

Locations (1)

Beijing Union Pharmaceutical Factory Ltd

Beijing, Beijing Municipality, China