Ankylosing Spondylitis
Conditions
Keywords
ankylosing spondylitis, loxoprofen, patch
Brief 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.
Interventions
DRUGLoxoprofen sodium hydrogel patch
100 mg per day
DRUGLoxoprofen sodium tablet
60 mg t.i.d.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20) | week 4 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASAS5/6 response | week 4 | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) |
| ASAS20 response | week 2 | 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) |
Countries
China
Outcome results
None listed