Open-label, Multicenter, Observational (Non-interventional) Study of Efficacy and Tolerability of Amtolmetin GuAcil in Subjects With Knee osTeoArthrosis With Dyspepsia. (AGATA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- Reduction in WOMAC score from baseline
研究概览
简要总结
This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.
详细描述
Osteoarthritis is the most common rheumatic disease. Knee OA (KOA), gonarthrosis (GA), is characterized by high prevalence, progressive course with early disability of the subject, persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs (NSAIDs) are actively used in clinical practice. It was revealed that NSAIDs may cause gastrointestinal adverse effects (AEs), from mild dyspepsia to bleeding and perforation as well as cardiovascular effects. Gastroprotection with misoprosol, Н2-receptor antagonists and proton pump inhibitors (PPI) is not always effective. NSAIDs with the lowest gastrointestinal toxicity with efficacy adequate to suppress joint pain is justified and reasonable.
Amtolmetin guacil (AMG) is a new NSAID which proved to be the least gastrointestinally toxic in experimental studies in vivo, in vitro and in comparative clinical studies. AMG does not have selectivity towards COX-2 or NO. AMG exerts gastroprotective effect due to stimulation of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. To assess tolerability of amtolmetin guacil, it is first necessary to obtain data on potential reduction of dyspeptic symptoms including in subjects with these signs of NSAIDs intolerability.
研究设计
- 研究类型
- Observational
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
- •Informed consent form for participation in the study;
- •KOA (based on ACR, 1987)
- •Age between 30-60 years old
- •Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)
- •Dyspeptic symptoms (according to SODA questionnaire)
- •Pain intensity in the investigated knee joint ≥ 40 mm according to VAS
- •Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against stable antihypertensive therapy.
排除标准
- •Contraindications to amtolmetin guacil (according to patient information leaflet)
- •Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg
- •Signs of renal or hepatic failure;
- •Pregnancy, lactation or planning for pregnancy.
- •One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.
研究组 & 干预措施
NISELAT
Amtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg
干预措施: NISELAT (Drug)
结局指标
主要结局
Reduction in WOMAC score from baseline
时间窗: Baseline to 4 weeks
Reduced WOMAC (according to pain, rigidity and function scales) by \> 20 % vs. baseline.
次要结局
- No of adverse events(Baseline to 4 week)
- Change in VAS(Baseline to 45 weeks)
- SODA Questionnaire(Baseline to 4weeks)