EUCTR2006-005048-97-CZ进行中（未招募）1 期
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY AND SAFETY OF 400MG/DAY LACOSAMIDE IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE
SCHWARZ BIOSCIENCES GmbH0 个研究点目标入组 190 人开始时间: 2007年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
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
- •Subjects must fulfill the following inclusion criteria:
- •1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •2. Subject is willing and able to comply with all trial requirements.
- •3. Subject is male or female and between 40 and 75 years of age.
- •4. Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
- •5. Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or
- •paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).
- •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
- •Subjects are not permitted to enroll in the trial if any of the following criteria are met:
- •1. Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.
- •2. Subject has participated in another trial of an investigational drug (or a physical stability treatment) within the last 30 days or is currently participating in another trial of an investigational drug (or physical stability treatment).
- •3. Subject has a history of chronic alcohol or drug abuse or dependence according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria (see Section 15.3, Criteria for substance abuse and substance dependence) within the last 2 years.
- •4. Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject’s ability to participate in this trial or could confound the analysis of efficacy.
- •5. Subject is taking analgesics (including herbal remedies) other than NSAIDs, COX-2
- •NSAIDs, and/or paracetamol/acetaminophen. Refer to Section 4.6, Concomitant
- •medications/treatments, for details on prohibited medications prior to Visit 1.
- •6. Subject is not able or willing to discontinue NSAIDs, COX-2 NSAIDs, and/or
- •paracetamol/acetaminophen during the course of the trial as directed by the protocol.
- •7. Subject plans to begin or stop treatment with glucosamine and/or chondrotin during the trial. Refer to Section 4.6, Concomitant medications/treatments, for details.
- •8. Subject plans to begin or stop chronic physical therapy regimen during the trial. Refer to Section 4.6, Concomitant medications/treatments, for details.
- •9. Subject has growth disturbances or crystal-induced arthropathies.
- •10. Subject has musculoskeletal disorders not attributed to osteoarthritis.
- •11. Subject has a history and/or diagnosis of a non-osteoarthritis pain syndrome, rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, septic arthritis, erosive inflammatory osteoarthritis or joint disease, or diffuse idiopathic skeletal hyperostosis.
- •12. Subject has other chronic conditions that cause significant pain unless subject can clearly distinguish this pain from that in the index knee. These cases should be discussed with the medical monitor.
- •13. Subject has a rating of =80mm in any element of the WOMAC VAS pain subscale at Visit 1.
- •14. Subject has had partial or complete joint replacement of the index knee or expects to schedule a surgical procedure including a knee replacement of the index knee during the course of the trial.
- •15. Subject has used a custom orthotic for less than 3 months.
- •16. Subject is using a walker or cane.
- •17. Subject has had active (redness, swelling, fever, etc) gout or pseudo-gout within 6 months prior to Visit 1.
- •18. Subject has Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondromatosis, heritable disorders (eg, hypermobility), or collagen gene mutations.
- •19. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin levels =2 times the upper limit of normal (ULN) or has alkaline phosphatase levels =3 times ULN at Visit 1.
- •20. Subject has impaired renal function, ie, creatinine clearance (CLcr) is lower than 50mL/min at Visit 1.
- •21. Subject has other laboratory values that are outside the normal range at Visit 1 and judged by the investigator as clini
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