CTRI/2009/091/000096已完成2 期
Maxi-Analgesic OA Study:Double-blind, Randomized, Parallel Group Comparison of the Effects of Paracetamol and Ibuprofen Combined (Maxigesic) with Paracetamol, Low and High Dose Ibuprofen on Patients with Pain from Osteoarthritis of the Knee
AFT Pharmaceuticals0 个研究点目标入组 32 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Provide written informed consent before initiation of any study-related procedures
- •2.Symptoms of OA of the knee for at least 6 months which has required analgesic medication
- •3.Be between 45-80 years of age inclusive on the day of consent
- •4.Physician opinion that long term medication for treatment of painful OA is indicated
- •5.Painful osteoarthritis of the study knee determined by the investigator with an average pain score of at least 40 and no more than 80mm on the WOMAC VAS pain scales following a 3-7 day washout of existing analgesics
排除标准
- •Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- •Study contra-indications
- •1.Symptoms of OA of both the knee and the hip that require treatment
- •2.Weight less than 50kg
- •3.Rheumatoid arthritis or other inflammatory arthritis
- •4.Gout or recurrent episodes of pseudogout
- •5.Paget?s disease
- •6.Articular fracture
- •7.Onchronosis
- •8.Acromegaly
- •9.Haemochromatosis
- •10.Wilson?s Disease
- •11.Primary Osteochondromatosis
- •12.Heritable disorders (e.g. hypermobility)
- •13.Oral or parenteral corticosteroids within 2 months or intra-articular hyaluronic acid within 9 months
- •14.Having taken any single dose of an NSAID or paracetamol within 12 hours prior to first dose of study drug
- •15.Known to be pregnant or possibly pregnant (serum -HCG test positive)
- •16.Woman of child bearing age who, in the opinion of the investigator, are not using reliable contraception
- •17.Alcohol intake
- •18.Suffering from a neurological disorder relating to pain perception
- •19.In the opinion of the investigator, unable to understand the visual analogue pain score
- •20.Currently, or in last 30 days, participating in a clinical trial involving another study drug
- •21.Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the patient?s best interests to participate in this study
- •NSAID and/or paracetamol contra-indications
- •1.Hypersensitivity to aspirin or other NSAID
- •2.Hypersensitivity to paracetamol
- •3.Severe known haemopoetic, renal or hepatic disease, immunosuppressed
- •4.History of gastric ulceration, indigestion, stomach pain or GI bleeding or bleeding disorders
- •5.Currently suffering from dehydration through diarrhoea and/or vomiting
- •6.History of severe asthma defined as previous steroid treatment or hospital admission
研究者
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