NCT00239382已完成3 期
A Randomized, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 15 mg IM Ampoules Once Daily and Meloxicam 15 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With RA.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Patient's assessment of overall pain
研究概览
简要总结
The objective of this trial was to assess the efficacy and safety of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with Rheumatoid arthritis over a time period of 7 days.
详细描述
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with rheumatoid arthritis over a time period of 7 days.
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet).
The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or above
- •The patient has rheumatoid arthritis, as defined by the American Rheumatism Association.
- •Assessment of overall pain (by the patient), after a washout for NSAID of at least 2 days (3 days for oxicams), must exceed 40 mm on a 100 mm visual analogue scale (VAS)
- •Symptoms of RA requiring administration of NSAIDs
- •Outpatients
- •Willingness and ability to provide written informed consent.
排除标准
- •Known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDs
- •Any clinical evidence of active peptic ulceration during the previous 6 months
- •Pregnancy or breastfeeding (precaution: attention should be drawn to reports that NSAIDs were reported to decrease the effectivity of intrauterine devices)
- •Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
- •Concomitant treatment with anti-coagulants (including heparin), lithium
- •Concomitant administration of other NSAIDs or analgesic agents (except paracetamol up to 4g/day)
- •Administration of any NSAID during the last 2 days (3 days for any oxicam) prior to the first administration of the trial drug
- •Concomitant treatment with methotrexate, sulfasalazine, D-penicillamine, chloroquine or any other disease modifying antirheumatic drug initiated or with an altered dose over the previous 3 months
- •Concomitant treatment with an oral corticosteroid initiated or with an altered dose over the previous month
- •Parenteral or intraarticular administration of corticosteroids in the previous month
- •Any i.m. injection during the previous 7 days
- •Synovectomy and/or surgical treatment for RA in the previous month or during the trial
- •Any physiotherapy which will be changed during the trial
- •Any contra-indication to i.m. injections
- •Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance, ulcerative colitis
- •Any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety
- •Serum creatinine 125 % of the upper limit of normal range ; aspartate amino-transferase (AST/SGOT) and/or alaline amino-transferase (ALT/SGPT) 200 % of the upper limit of normal range
- •Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3
- •Participation in another clinical trial during this study or during the previous month
- •Previous participation in this trial (i.e. having been allocated a randomized treatment number)
- •Patient unable to comply with the protocol
结局指标
主要结局
Patient's assessment of overall pain
时间窗: 7 days
Patient's global assessment of disease activity
时间窗: 7 days
次要结局
- Patient's assessment of physical function(7 days)
- Investigator's Global Assessment of Disease Activity(7 days)
- Tender/Painful Joint Count(7 days)
- Swollen Joint Count(7 days)
- Duration of Morning Stiffness(7 days)
- Final Global Assessment of Efficacy by Patient(7 days)
- Final Global Assessment of Efficacy by Investigator(7 days)
- Withdrawals due to Inadequate Efficacy(7 days)
- Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient(7 days)
- Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator(7 days)
- Onset of Analgesic Action(7 days)
- Paracetamol Consumption(7 days)
- Time to Maximum Pain Relief After the First Trial Drug Administration(7 days)
研究者
研究点 (12)
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