Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- Serum creatinine change
研究概览
简要总结
2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.
详细描述
The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI > 4
排除标准
- •Inadequate response to therapeutic dose of indomethacin or etoricoxib, taken for at least 2 weeks continuously
- •Abnormal serum creatinine : serum creatinine >1.3 mg/dl
- •Abnormal SGPT: SGPT > 40 U/L
- •Hypertension: Systolic blood pressure > 140 mm Hg and/ or diastolic blood pressure >90 mm Hg or on anti-hypertensive drug
- •Dyspepsia or active peptic ulcer disease : upper abdominal discomfort or upper abdominal pain related with food or peptic ulcer disease diagnosed by upper gastrointestinal endoscopy
- •Diabetes mellitus: abnormal random plasma glucose or diagnosed case of diabetes mellitus
- •Ischemic heart disease: history of angina or ECG changes suggestive of ischemic heart disease
- •Active congestive heart failure: pedal edema with tender hepatomegaly with raised JVP or diastolic dysfunction on echocardiography
- •Asthma: diagnosed case of asthma or rhonchi on chest auscultation
- •Bleeding problems: having a history of prolonged bleeding
- •Pregnancy: missed period followed by positive pregnancy test
- •Simultaneous use with certain medications such as warfarin, phenytoin, cyclosporine, probenecid, lithium, digoxin, ACE inhibitor, thiazide
研究组 & 干预措施
Group A in phase 1
Indomethacin 75 mg, extended release capsule twice daily
干预措施: Indomethacin SR, 75 Mg Oral Capsule, Extended Release (Drug)
Group B in phase 1
Indomethacin 25 mg capsule, 2 capsule twice daily
干预措施: Indomethacin 25 Mg Oral Capsule (Drug)
Group A in phase 2
Etoricoxib 90 mg once daily
干预措施: Etoricoxib 90 mg (Drug)
Group B in phase 2
Etoricoxib 60 mg once daily
干预措施: Etoricoxib 60 mg (Drug)
结局指标
主要结局
Serum creatinine change
时间窗: 3rd week and 24th week
change in serum creatinine \>25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients
次要结局
- Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)(3rd week and 24th week)
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(3rd week and 24th week)
研究者
Khandker Mahbub-Uz-Zaman
Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh