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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Loxoprofen sodium hydrogel patch
* Drug: Loxoprofen sodium tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LX-P group<br>loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks | Drug: Loxoprofen sodium hydrogel patch<br>* 100 mg per day<br>* Other names: Loxoprofen hydrogel patch;|
| Active Comparator: LX-T group<br>loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks | Drug: Loxoprofen sodium tablet<br>* 60 mg t.i.d.<br>* Other names: Loxoprofen tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20) | ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI) | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASAS5/6 response | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) | week 4 | 
| ASAS20 response | ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI) | week 2 | 
| ASAS5/6 response | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) | week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankylosing spondylitis, loxoprofen, patch