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

Sun Yat-sen University

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Loxoprofen sodium tablet; Drug: Loxoprofen sodium hydrogel patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03800797

[2014]2-135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

LX-P group

Experimental group

Description:

loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks

Treatment:

Drug: Loxoprofen sodium hydrogel patch

LX-T group

Active Comparator group

Description:

loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks

Treatment:

Drug: Loxoprofen sodium tablet