NCT02121002已完成3 期
A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,176
- 试验地点
- 22
- 主要终点
- Change From Baseline to 4 Weeks in WOMAC Pain Score
研究概览
简要总结
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
- •Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
- •After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
- •If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
- •Able to tolerate rescue medication with paracetamol/acetaminophen.
排除标准
- •Pregnant or lactating or planning to become pregnant during the study period.
- •X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
- •History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- •After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
- •History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
- •History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
- •History of gastrointestinal bleeding or peptic ulcer disease.
- •Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
- •Elevated transaminases at screening.
- •Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.
- •Concomitant use of corticosteroids or use within 30 days of study randomization.
- •Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
- •Known allergy to aspirin or nonsteroidal anti-inflammatory drug
- •Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
- •Receipt of any drug as part of a research study within 30 days prior to screening.
- •Previous participation in this study.
- •Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
- •Recent history of major knee injury or surgery.
- •Known history of positive HIV
研究组 & 干预措施
Diclofenac Sodium Topical Gel, 1%
Experimental
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
干预措施: Diclofenac Sodium Topical Gel, 1% (Drug)
Voltaren Topical Gel, 1%
Active Comparator
Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
干预措施: Voltaren Topical Gel, 1% (Drug)
Vehicle Diclofenac Sodium Topical Gel
Placebo Comparator
Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
干预措施: Vehicle Diclofenac Sodium Topical Gel (Drug)
结局指标
主要结局
Change From Baseline to 4 Weeks in WOMAC Pain Score
时间窗: Baseline and Week 4
Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
次要结局
未报告次要终点
研究者
研究点 (22)
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