NCT00904605终止4 期
A Randomized, Open-Label Study Comparing the Efficacy and Safety of Lidocaine Patch 5% With Celecoxib 200 mg in Patients With Pain From Osteoarthritis of the Knee
Endo Pharmaceuticals0 个研究点开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 主要终点
- Mean change from baseline to Week 12 in Western Ontario and McMaster Universities OA Index (WOMAC) pain subscale
研究概览
简要总结
Patients with unilateral or bilateral osteoarthritis of the knee participated in a Phase IV clinical trial to assess the efficacy of Lidoderm compared with celecoxib 200mg in treating pain from osteoarthritis of the knee.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had unilateral or bilateral OA of the knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence of OA (presence of osteophytes on x-ray and written evaluation)
- •Had functional capacity class rating of I, II, or III according to ACR classification
- •Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
- •Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for non-study pain)
- •At baseline visit, patients were randomized to active treatment if they had an average daily pain intensity score for the index joint of 5 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately preceding the baseline visit; 0 is defined as "no pain" and 10 is defined as "pain as bad as ever imagined" as measured by Question 5 of the BPI and recorded in a diary.
- •At baseline visit, patients were randomized to active treatment if they had an OA severity score for the index joint of 7 or greater on a composite scale of 0 to 24 as measured by the Index of Severity for Osteoarthrosis of the Knee
排除标准
- •Had been diagnosed with inflammatory arthritis, gout, pseudo-gout or Paget's disease that in the investigator's opinion would interfere with the assessment of pain and other symptoms of OA
- •Had elective surgery scheduled to occur during the 14-week study
- •Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that may confound study results
- •Had any other clinically significant joint disease or prior joint replacement surgery at the index joint
- •Had severe renal insufficiency (creatinine clearance of <30 mL/min)
- •Had moderate or greater hepatic impairment
- •Had experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- •Had a prior history of peptic ulcer disease and/or gastrointestinal bleeding
- •Were taking analgesic medications, glucosamine, or chondroitin that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
- •Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the washout period.
- •Were receiving fluconazole or lithium (secondary to drug-drug-interaction risks)
- •Were taking a lidocaine-containing products that could not be discontinued during the study
- •Had previously failed treatment with Lidoderm analgesic patch for OA
- •Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry
- •Were unable to discontinue use of topic drugs applied to the knee
- •Had previously failed treatment with celecoxib or with two COX-2 specific inhibitors other than celecoxib
- •Were taking class I anti-arrhythmic drugs (e.g. mexiletine, tocainide)
研究组 & 干预措施
1- Lidoderm®
Experimental
Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied topically to each affected knee every 24 hours (q24h)
干预措施: Lidoderm (Drug)
2-Celecoxib 200mg
Active Comparator
Celecoxib (Celebrex®, G.D. Searle & Co., Chicago, IL), one 200 mg oral capsule QD
干预措施: Celecoxib (Drug)
结局指标
主要结局
Mean change from baseline to Week 12 in Western Ontario and McMaster Universities OA Index (WOMAC) pain subscale
时间窗: Visits - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
次要结局
- Safety assessments included AEs, Dermal assessment (lidocaine group only), skin sensory testing (lidocaine group only), clinical laboratory test results (including urinalysis), vital sign measurements, physical examination results, body weight, plasma
研究者
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