NCT03872830

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-exploratory Phase II Clinical Trial to Evaluating the Efficacy and Safety of Felbinac Trometamol Injection in the Treatment of Moderate to Severe Pain After Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled, dose-exploratory phase II clinical trial to evaluating the efficacy and safety of Felbinac Trometamol Injection in the treatment of moderate to severe pain after surgery.Main purpose is preliminary evaluation the effectiveness of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to explore the dosage regimen of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery, and provide data support for later clinical trial.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Felbinac Trometamol Injection	Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump. One dose at 8h and 16h 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 3 times,3 times/day,once every 8 hours.
DRUG	Placebos	Placebo diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump. One dose at 8h and 16h 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 3 times,3 times/day,once every 8 hours.

Timeline

• Start date: 2019-03-27
• Primary completion: 2019-09-30
• Completion: 2019-12-05
• First posted: 2019-03-13
• Last updated: 2020-07-07

Locations

1 site across 1 country: China