A Randomized, Double Blind, Three-arm, Parallel, Placebocontrolled, Clinical Study to Evaluate the Bioequivalence Using Clinical Endpoint of Diclofenac Sodium Gel, 1% (Mylan Inc.) 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
- 入组人数
- 1,220
- 试验地点
- 32
- 主要终点
- Change From Baseline in WOMAC Pain Subscale Score
研究概览
简要总结
This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.
Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria
Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.
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
- Quadruple (Participant, Care Provider, 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
- •Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
- •Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
- •After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
- •After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
- •Able to tolerate rescue medication with acetaminophen
- •Subjects who can read and understand WOMAC pain sub scale
排除标准
- •Pregnancy, lactation
- •OA of Kellgren-Lawrence grade 4
- •OA pain in the contralateral knee requiring medication (OTC or prescription)
- •History of OA of either Hip or Hands
- •History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
- •History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
- •History of Drugs or Alcohol abuse within the previous year
- •Symptomatic peripheral vascular disease of the study leg
- •Any musculoskeletal condition
- •Skin disease at the application site
- •Active asthma requiring periodic treatment with systemic steroids
- •Known history of positive HIV, hepatitis C virus, or HBsAg
- •Uncontrolled hypertension
- •History of myocardial infarction, thrombotic events, stroke etc.
- •Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
研究组 & 干预措施
Diclofenac Sodium Gel
Diclofenac Sodium Gel, 1%
干预措施: Diclofenac sodium gel 1% (Drug)
Voltaren® Gel
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
干预措施: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Drug)
Placebo gel
Placebo gel
干预措施: Placebo gel (Drug)
结局指标
主要结局
Change From Baseline in WOMAC Pain Subscale Score
时间窗: 4 weeks
Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the superiority of the Test Drug and Reference Listed Drug (RLD) over placebo. Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.
Mean Change in the Total WOMAC Pain Subscale Score
时间窗: From baseline to week 4
Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the clinical equivalence of Test Drug (Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD) (Voltaren® Gel 1% of Novartis Consumer Health, Inc.) Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.
次要结局
未报告次要终点