NCT03800797

Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis

Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

Detailed description

This is a 4-week randomized, open-label trial to investigate the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Loxoprofen sodium hydrogel patch	100 mg per day
DRUG	Loxoprofen sodium tablet	60 mg t.i.d.

Timeline

• Start date: 2015-05-25
• Primary completion: 2015-12-10
• Completion: 2015-12-10
• First posted: 2019-01-11
• Last updated: 2019-01-11

Locations

1 site across 1 country: China