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

• Status: Completed
• Trial end date: 2015-12-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Loxoprofen

Criteria

Inclusion Criteria:

• 18 to 65 years

• Meet 1984 modified New York criteria for AS

• The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3

• NSAIDs washout period of at least 5 days prior to randomization

• DMARDs washout period of at least 4 weeks prior to randomization

• Corticosteroids washout period of at least 4 weeks prior to randomization

• Biological agents washout period of at least 3 months prior to randomization.

Exclusion Criteria:

• Peptic ulcer

• Unstable cardiac diseases

• Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits

• Abnormal renal function with creatinine more than upper normal limit

• Hematologic disorders

• Psychosis

• Malignancy

• Allergic to LX drug.