NCT01456611已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients 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
- 749
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in WOMAC Pain Scale
研究概览
简要总结
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in patients with osteoarthritis of the knee.
The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.
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
- •Ambulatory Male and Non Pregnant Females 35 years and older diagnosed with osteoarthritis (according to the American College of Rheumatology Criteria) in one or both knees.
- •ACR Criteria includes, Knee Pain and at least 3 of the following:
- •stiffness lasting < 30 mins
- •bony tenderness
- •bony enlargement
- •no palpable warmth
- •Symptom onset of > 6 Months prior to Screening for the target knee.
- •If female and of child-bearing potential, prepare 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).
- •Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc) requiring the use of oral or topical treatments (NSAIDS or acetaminophen) for > 15 days in the 30 days prior to Screening.
- •Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease based upon the Kellgren-Lawrence disease severity scale.
- •After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 50mm on a 100-mm Visual Analogue Scale for the target knee.
- •After a 7 day wash out of all pain medication has baseline WOMAC pain sub scale of ≥ 9 on a 5 question, 5 point (0 to 4) Likert scale for the target knee.
- •Willing and able to use only acetaminophen as rescue medication
- •Willing and able to comply with the study requirements.
排除标准
- •Females who are pregnant, breast feeding, or planning a pregnancy
- •Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale. 24
- •History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
- •After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 20mm on a 100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
- •Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) or rheumatoid arthritis.
- •Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.
- •History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
- •History of coronary artery bypass graft within 6 months of screening.
- •Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
- •Use of warfarin or other anticoagulant therapy within 30 days of screening.
- •Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of screening or during the study.
- •Known history of gastrointestinal bleeding or peptic ulcer disease.
- •Abnormal screening clinical laboratory evaluations which the Investigator determines are clinically significant.
- •Known allergy to aspirin or NSAIDs.
- •Results from liver function tests that are more than two times the upper limit of the normal range at screening.
- •Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the Patient at risk by participating in the study.
- •Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
- •Receipt of any drug as part of a research study within 30 days prior to screening.
- •Previous participation in this study.
研究组 & 干预措施
Diclofenac Sodium Gel
Experimental
Diclofenac sodium Topical Gel 1%
干预措施: Diclofenac (Drug)
Voltaren (R) Gel
Active Comparator
Voltaren (R) Gel 1%
干预措施: Diclofenac (Drug)
Placebo
Placebo Comparator
Placebo Topical Gel
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change from Baseline in WOMAC Pain Scale
时间窗: Baseline and Week 4
次要结局
- Superiority of Test and Reference against Placebo in the Mean Change from baseline in the total WOMAC pain score.(Baseline and Week 4)
研究者
研究点 (1)
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