CTRI/2015/09/006149已完成未知
A Prospective, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Bioequivalence Study with Clinical Endpoints Comparing Generic Diclofenac Sodium Topical Gel 1% of Cipla Ltd., India to Voltaren® Gel (a Diclofenac Sodium Topical Gel 1%) of Endo Pharmaceuticals Inc., USA in Subjects with Osteoarthritis of the Knee.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 990
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •A subject will be eligible for inclusion in the study if he / she fulfils the following criteria:
- •1.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:
- •a.Pain in the knee and presence of at least 3 of the following ACR criteria: age >= 50 years; stiffness lasting for < 30 min; bony tenderness; crepitus; bony enlargement; no palpable warmth, and including:
- •i.Symptoms for at least 6 months prior to screening, and
- •ii.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
- •iii.The pain in the target knee required the use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen / paracetamol (topical or oral treatments)
- •2.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
- •3.After discontinuing all pain medications for at least 7 days, had at least moderate POM for target knee, defined as a baseline score of >= 50 mm on a 0-100 mm VAS immediately prior to randomization, and a baseline WOMAC pain subscale of at least 9 immediately prior to randomization
- •4.Able to tolerate rescue medication (i.e., acetaminophen / paracetamol)
- •5.Subjects willing to refrain from using any other OA treatment during the 4-week treatment period, other than the study treatment, and rescue medication
- •6.Subjects willing to give written informed consent and provide audio-visual recording of the consent process
- •7.Willing and able to comply with the study requirements
- •8.Not pregnant / not planning to be pregnant / not a lactating female. Women of childbearing potential and male subjects were included in the study if they are willing to use an appropriate method of contraception
排除标准
- •A subject will not be eligible for inclusion in this study if he / she meets any of the following criteria:
- •1.X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease
- •2.History of OA pain in the contralateral knee requiring medication within 1 year prior to screening
- •3.After discontinuing all pain medications for at least 7 days, had a baseline score of >= 20 mm on a 0-100 mm VAS for the contralateral knee immediately prior to randomization
- •4.History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia
- •5.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease
- •6.History of gastrointestinal (GI) bleeding or peptic ulcer disease
- •7.Known allergy to aspirin or NSAID
- •8.Elevated transaminases at screening (i.e., AST or ALT more than 2 times the upper limit of normal at screening visit)
- •9.Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past 30 days prior to entry into the study
- •10.Concomitant acetyl salicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162 mg daily) taken for at least 3 months prior to enrolment and maintained throughout the duration of the study
- •11.Any other topical products applied to the target site
- •12.Use of systemic corticosteroid or immunosuppressive drugs
- •13.Use of pain medication other than acetaminophen / paracetamol
- •14.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of the study data or place the subject at risk by participating in the study
- •15.Receipt of any drug as a part of a research within 30 days prior to screening
- •16.Previous participation in this study
- •17.Recent history of knee injury or surgery
- •18.Subjects who are alcohol or drug dependent i.e. substance of abuse
- •19.Subjects having clinically significant liver, kidney, or cardiac dysfunction
- •20.Subjects having history of hypersensitivity reactions to diclofenac sodium gel or any of its excipients
- •21.A positive serology test result for HIV antibody (I & II), HBsAg, and / or HCV antibodies
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