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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 194
- 主要终点
- Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period
研究概览
简要总结
The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.
详细描述
LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe.
The study has an adaptive 3-stage group sequential design.
The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period.
The last subject is expected to be enrolled in December 2007.
The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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).
排除标准
- •Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
- •Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
- •Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial
研究组 & 干预措施
Lacosamide
lacosamide (LCM)
干预措施: lacosamide (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period
时间窗: Baseline, end of 8 week Maintenance Period
The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.
次要结局
- Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.(Baseline, end of 8 week Maintenance Period)
- Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep.(Baseline, end of 8 week Maintenance Period)
- Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).(Baseline, end of 8 week Maintenance Period)
- Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.(at the end of 8 week Maintenance Period)
- Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).(Baseline, end of 8 week Maintenance Period)
- Amount of Rescue Medication Use During 8 Week Maintenance Period.(during 8 week Maintenance Period)
- Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.(Baseline, end of 8 week Maintenance Period)
- Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.(Baseline, end of 8 week Maintenance Period)