CTRI/2015/09/006149已完成不适用
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
- 不适用
- 状态
- 已完成
- 入组人数
- 990
- 试验地点
- 18
- 主要终点
- The primary efficacy endpoint of the study is:
研究概览
简要总结
This isprospective,randomized,double-blind,vehicle-controlled.parellel group,bioequivalence clinical trial to compare clinical efficacy, safety and tolerabilityof generic Diclofenac Sodium Topical Gel 1%,with Voltaren® Gel (aDiclofenac Sodium Topical Gel 1%) and Vehicle of Diclofenac Sodium Topical Gel1% in approximately 23 centers. A minimum 990 subjects (330 in each treatment group) with osteoarthritis (OA) of theknee.
Primary efficacy endpoint of the study is:
· Mean change in theWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) painscore in target knee from baseline to week 4
The secondary efficacy endpoints of the study are:
· Mean change in painon movement (POM) on a Visual Analog Scale (VAS) for target knee from baselineto week 4
· Mean change in patient globalassessment (PGA) score from baseline to week 4
TheSafety endpoints of the study are:
- Proportion of subjects with adverse events (AEs) and serious adverse events
- Change in physical examination, vital signs, andclinical laboratory tests (hematology and biochemistry parameters) frombaseline to week 4
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
The primary efficacy endpoint of the study is:
时间窗: 4 weeks.
Mean change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score in target knee from baseline to week 4.
时间窗: 4 weeks.
次要结局
- The secondary efficacy endpoints of the study are:(Mean change in pain on movement (POM) on a Visual Analog Scale (VAS) for target knee from baseline to week 4.)
- The Safety endpoints of the study are:(Proportion of subjects with adverse events (AEs) and serious adverse events.)
研究者
研究点 (18)
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