NCT00239395已完成3 期
A Randomised, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg IM Ampoules Once Daily and Meloxicam 7.5 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With Osteoarthritis (OA)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Pain on active movement by VAS.
研究概览
简要总结
The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis 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 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.
The primary endpoint: Pain on active movement,
The secondary endpoint:
- Pain at rest
- Patient status with regard to change of arthritic condition assessed by the patient/investigator
- Patient's assessment of arthritic condition
- Onset of action
- Time to maximum pain relief
- Paracetamol consumption
- Withdrawals due to inadequate efficacy
- Final global assessment of efficacy by the patient/investigator
Safety endpoints
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
- •Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or knee.
- •The diagnosis must be based on
- •clinical signs and symptoms or
- •x-ray diagnosis plus clinical signs and symptoms
- •Assessment of pain on active movement (by the patient) must exceed 40 mm on a 100 mm visual analogue scale (VAS)
- •Symptoms of OA requiring administration of NSAIDs
- •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 last six 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 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
- •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 transferase (AST/SGOT) and/or alkaline transferase (ALT/SGPT) 200 % of the upper limit of normal range
- •Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3
- •Synovectomy in the previous month or during the trial
- •Participation in another clinical trial during this study or during the previous month
- •Previous participation in this trial
- •Patient unable to comply with the protocol
- •Concomitant therapy with specific symptomatic drug of OA, such as chondroitin sulphate, diacerhein, initiated or with an altered dose over the previous 3 months.
- •Intraarticular administration of hyaluronic acid in the previous month
- •Patients where physiotherapy will be changed throughout the study
结局指标
主要结局
Pain on active movement by VAS.
时间窗: day 0, day 7
次要结局
- Withdrawals due to inadequate efficacy(up to 7 days)
- Final global assessment of efficacy by investigator(up to 7 days)
- Assessment of local tolerability(up to 7 days)
- Change in other laboratory investigations(up to 7 days)
- Patient status with regard to change of arthritic condition(up to 7 days)
- Pain at rest(up to 7 days)
- Patient's and investigator's assessment of overall tolerability(up to 7 days)
- Nature and severity of adverse events(up to 7 days)
- Onset of Analgesic action(up to 7 days)
- Time to maximum pain relief(up to 7 days)
- Paracetamol consumption(up to 7 days)
- Final global assessment of efficacy by patient(up to 7 days)
- Withdrawals due to safety reasons(up to 7 days)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid ArthritisArthritis, RheumatoidNCT00239382Boehringer Ingelheim150
已完成
4 期
Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or LaryngitisPharyngitisNCT02229747Boehringer Ingelheim128
已完成
4 期
Effect of Meloxicam Tablets on Bleeding Time in Healthy SubjectsHealthyNCT02183155Boehringer Ingelheim82
已完成
2 期
Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitisPharyngitisNCT02183038Boehringer Ingelheim390
已完成
4 期
Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the KneeOsteoarthritisNCT02183129Boehringer Ingelheim91