ISRCTN77199439已完成不适用
A randomised, double-blind, parallel group, multiple-dose 3 month study of ibuprofen 400 mg alone, paracetamol (acetaminophen) 1000 mg alone, ibuprofen 200 mg plus paracetamol 500 mg and ibuprofen plus paracetamol 1000 mg, all taken three times daily, in community patients with chronic knee pain
RB Corporate Services Ltd (UK)0 个研究点目标入组 800 人开始时间: 2008年5月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
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. Age 40 years and over, both males and females
- •2. Primary diagnosis of knee pain, as evidenced by the presence of pain in or around at least one knee for most days over the last 3 months and on at least four of the seven days preceding screening visit
- •3. Pain of the signal knee prior to provision of study medication and where necessary, after an appropriate washout period on discontinuation of any current analgesic medication, at a level of >30mm and <80 mm on the visual analogue scale (VAS) (pain experienced in the previous 24 hours walking on the flat)
- •4. Be anticipated to require continuous treatment to control pain for the duration of the study
- •5. Have a Steinbrocker functional capacity classification of 1-3
- •6. Be registered with a general practitioner
- •7. Be able to give written informed consent
排除标准
- •1. Concomitant other major rheumatic disease (including rheumatoid arthritis, gout and sero-negative arthropathies) or other painful conditions which could interfere with the accurate assessment of the signal knee, or acute joint trauma of the signal knee or a lower limb joint prosthesis
- •2. An anticipated need for any major surgical procedure or any invasive procedure that would be performed on either knee during the course of the study
- •3. An active malignancy of any type (subjects who have a history of basal cell carcinoma that has been successfully treated are eligible). Subjects with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before
- •study enrolment are also eligible)
- •4. An active or suspected peptic or duodenal ulceration or gastrointestinal bleeding or severe dyspepsia experienced for most days of the previous month
- •5. Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any previous history of allergy or known intolerance to any of the drugs or formulation constituents which, in the Investigator's opinion, might preclude use of an non-steroidal anti-inflammatory drug (NSAID), including aspirin sensitive asthma or a previous allergic response to a NSAID, including bronchospasm, urticaria, angioedema and rhinitis
- •6. Ankle oedema
- •7. Concomitant medications and treatments: Receipt of any intra-articular hyaluronate in the previous 6 months, or intra-articular corticosteroids within 3 months to the signal joint or intra-articular corticosteroid to any joint within the previous 1 month, or intra-muscular (i.m.) corticosteroid or per oral (p.o.) steroid within the previous month or fluid evacuation without steroid injection, or any drug intended to modify joint structure or function; Subjects taking >325 mg aspirin per day for non-arthritic reasons, if stable for at least 30 days prior to first dose of study medication, are eligible; If the patient uses a cane or other assisted devices at time of initial evaluation, then the usage must remain unchanged. If the patient is undergoing physiotherapy at the time of initial evaluation, then the regimen must remain unchanged throughout the study
- •8. An anticipated need for treatment with other analgesics (such as opiodis/narcotics) during the course of the study
- •9. Abnormal pre-treatment laboratory test values >1.5 times the upper limit of normal (ULN) for either aspartate transaminase (AST; SGOT) or alanine transaminase (ALT; SGPT) or any other laboratory abnormalities considered by the Investigator to be clinically significant. If such a value is found at screening, the patient must be excluded
- •10. Abuse of alcohol, as evidenced by averaging more than 21 units per week for men or 14 units for women
- •11. Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy). Women of childbearing potential practising sexual abstinence, and those with a partner who has had a vasectomy, who
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