ISRCTN66676866已完成不适用
An open label study to assess the effectiveness of oral methotrexate at reducing pain in knee osteoarthritis
niversity of Leeds (UK)0 个研究点目标入组 30 人开始时间: 2011年5月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 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 greater than or equal to 40 mm on a Visual Analogue Scale (VAS) (0 - 100 mm) using the question On average, how would you rate your knee pain during the last 3 months?
- •5. Fulfil clinical American College of Rheumatology (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 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
- •10. All patients with pre-existing lung disease/smokers must have had a chest radiograph (X-Ray) within the last 6 months
- •11. Aged 53 - 85 years, either sex
排除标准
- •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 or the use of depo corticosteroid injection within the 6 months preceding enrolment in the study
- •3. Use of intra-articular corticosteroid injections in the 3 months preceding enrolment
- •4. The use of oral or parenteral steroids in the 2 months preceding the study
- •5. Knee injury or diagnostic arthroscopy within the 6 months preceding enrolment in the study
- •6. A history of knee surgery in the signal knee at any time
- •7. The presence of non-OA causes of pain in the signal knee, e.g. referred hip pain, osteonecrosis
- •8. 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)
- •9. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer
- •10. Significant haematological or biochemical abnormality:
- •10.1. Haemoglobin less than or equal to 8.5 g/dL
- •10.2. White cell count (WCC) less than or equal to 3.5 x 109/L
- •10.3. Neutrophils less than or equal to 1.5 x 109/L
- •10.4. Platelets less than or equal to 100 x 109/L
- •10.5. Alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN) for the laboratory conducting the test
- •10.6. Creatinine greater than 1.5 times ULN for the laboratory conducting the test
- •11. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
- •12. Intake of alcohol above the recommended government guidelines (2 units per day for women, 3 units per day for men)
- •13. 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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