CTRI/2014/03/004474进行中（未招募）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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,176
- 试验地点
- 35
- 主要终点
- The primary efficacy endpoint will be the mean change from baseline to week 4 in the WOMAC pain score
研究概览
简要总结
This will be randomized, multi-center, double blind, vehicle controlled, parallel group study to be performed at approximately 35 study sites located in India. The randomized subjects will be enrolled in a 1:1:1 ratio.The primary efficacy end point in the study is the mean change from baseline to week 4 in the WOMAC pain score (pain score= 0 to 20), which will be determined by the subjects responses to five questions (S1-S5) using a 5-point likert scale (i.e., none=0, mild=1, moderate=2, serve=3, extreme=4). The questions pertain to the amount of pain the subject is currently experiencing in the target knee [i.e., 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)]
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study.
- •2.Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee including: •Presence of at least three (3) of the American College of Rheumatology (ACR) criteria (age ≥ 50; stiffness lasting < 30 mins; bony tenderness; crepitus; bony enlargement; no palpable warmth) •Symptoms for at least 6 months prior to screening, AND •Knee (not referred) pain for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.), AND •The pain in the target knee required the use of NSAIDs or paracetamol/ acetaminophen (topical or oral treatments).
- •3.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.
- •4.After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement (POM) for target knee, defined as a baseline score of ≥ 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization, AND a baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of at least 9 immediately prior to randomization.
- •5.If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
- •6.Able to tolerate rescue medication with paracetamol/acetaminophen.
- •7.Willing and able to comply with the study requirements.
排除标准
- •1.Pregnant or lactating or planning to become pregnant during the study period.
- •2.X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
- •3.History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening.
- •4.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.
- •5.History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
- •6.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
- •7.History of gastrointestinal bleeding or peptic ulcer disease.
- •8.Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
- •9.Elevated transaminases at screening (AST or ALT more than 2 times the upper limit of normal at screening visit).
- •10.Use of ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within 30 days of study randomization.
- •11.Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
- •12.Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
- •13.Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- •14.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.
- •15.Receipt of any drug as part of a research study within 30 days prior to screening.
- •16.Previous participation in this study.
- •17.Any use between screening and baseline of a treatment or medication that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
- •18.Recent history of major knee injury or surgery.
- •19.Known history of positive HIV.
结局指标
主要结局
The primary efficacy endpoint will be the mean change from baseline to week 4 in the WOMAC pain score
时间窗: Assessment of WOMAC scale from Day 1 to Day 28
次要结局
- not applicable(not applicable)
研究者
研究点 (35)
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