Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
LX-P group
loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks
干预措施: Loxoprofen sodium hydrogel patch (Drug)
LX-T group
loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks
干预措施: Loxoprofen sodium tablet (Drug)
结局指标
主要结局
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
时间窗: 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)
次要结局
- ASAS5/6 response(week 2)
- ASAS20 response(week 2)
研究者
Gu Jieruo
Director, Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-Sen University
Sun Yat-sen University