NCT04526132

A Phase Ⅲ Clinical Study Trial of Felbinac Trometamol Injection in China

A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase Ⅲ Clinical Trial on the Efficacy and Safety of Felbinac Trometamol Injection in the Treatment of Moderate and Severe Postoperative Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of moderate and severe postoperative pain.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Felbinac Trometamol Injection	Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).. One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours.
DRUG	Placebos	Placebo diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min). One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours.

Timeline

• Start date: 2021-04-25
• Primary completion: 2021-12-29
• Completion: 2022-06-30
• First posted: 2020-08-25
• Last updated: 2023-05-22

Locations

1 site across 1 country: China