A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,164
- 试验地点
- 44
- 主要终点
- Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
研究概览
简要总结
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) 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
- Triple (Participant, Investigator, Outcomes Assessor)
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 male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.
- •OA Symptoms for at least 6 months prior to screening.
- •Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20 point scale for the target knee immediately prior to randomization.
排除标准
- •History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- •History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
- •History of gastrointestinal bleeding or peptic ulcer disease.
- •Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- •Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
- •Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
研究组 & 干预措施
Voltaren® Gel
apply gel to the target knee
干预措施: Voltaren® Gel (Drug)
Diclofenac Sodium gel, 1%
apply gel to the target knee
干预措施: Diclofenac Sodium gel, 1% (Drug)
Placebo
apply gel to the target knee
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
时间窗: Baseline and week 4
The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
次要结局
未报告次要终点