EUCTR2008-008237-11-GB进行中（未招募）不适用
An open label study to assess the effectiveness of oral methotrexate in reducing pain in knee osteoarthritis - Pain Reduction in Osteoarthritis using oral Methotrexate
niversity of Leeds0 个研究点开始时间: 2010年7月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Knee pain on most days in the last 3 months.
- •2.Insufficient pain relief from, or inability to tolerate NSAIDs and/or opioids.
- •3.Patient able to identify a predominantly painful knee (the signal knee).
- •4.Moderate to severe pain of the signal knee as defined by a score of =40mm on a VAS (0-100mm) using the question On average, how would you rate your knee pain during the last 3 months?”
- •5.Fulfil clinical ACR Criteria for knee OA.
- •6.A previous radiograph (X-Ray) of the signal knee with changes consistent with osteoarthritis.
- •7.Men and women must use adequate birth control measures (e.g. abstinence, oral contraceptives, Intra-uterine device, barrier method with spermicide, or surgical sterilisation) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion or dose of methotrexate. If female and have potential for child bearing then a negative pregnancy test must be performed prior to starting treatment.
- •8.The patient must be able to adhere to the study visit schedule and other protocol requirements.
- •9.The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.1.The presence of any rheumatic diseases that could be responsible for secondary osteoarthritis.
- •2.Use of intra-articular hyaluronic acid in the signal knee within the 6 months preceding enrolment in the study
- •3.The use of oral, parenteral, intra-articular or intra-muscular steroids in the 2 months preceding enrolment into the study
- •4.Knee injury, diagnostic arthroscopy or knee surgery within the 3 months preceding enrolment in the study
- •5.The presence of non-OA causes of pain in the signal knee, e.g. referred hip pain, osteonecrosis.
- •6.Women who are pregnant, nursing, or men or women planning pregnancy within 12 months after screening (i.e. approximately 6 months following last study medications).
- •7.Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- •8.Significant haematological or biochemical abnormality
- •a.Haemoglobin?8.5 g/dL
- •b.WCC?3.5 x 109/L
- •c.Neutrophils?1.5 x 109/L
- •d.Platelets?100 x 109/L
- •e.ALT?2 times ULN for the laboratory conducting the test.
- •f.Creatinine > 1.5 times ULN for the laboratory conducting the test
- •9.Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- •10.Intake of alcohol above the recommended government guidelines (2 units per day for women, 3 units per day for men).
- •11.Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.
研究者
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