Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Registration Number
- NCT03800797
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LX-P group Loxoprofen sodium hydrogel patch loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks LX-T group Loxoprofen sodium tablet loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ASAS5/6 response week 2 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)
Trial Locations
- Locations (1)
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China