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

Sun Yat-sen University70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ankylosing Spondylitis

Interventions

Loxoprofen sodium hydrogel patchDRUG

100 mg per day

Loxoprofen sodium tabletDRUG

60 mg t.i.d.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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)

Time frame: week 4

Secondary Outcomes

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)

Time frame: week 4

ASAS20 response

Time frame: 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)

Time frame: week 2

Data from ClinicalTrials.gov

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