CTRI/2023/12/060871进行中（未招募）不适用
A Randomized, Double-Blind, Multicenter, Three-Arm, Placebo-Controlled, Parallel-Design, Bioequivalence Study with Clinical Endpoints comparing Diclofenac Diethylamine Gel 1.16% of Encube Ethicals Private Limited, India with Voltaren Schmerzgel 11.6 mg/g (Diclofenac Diethylamine Gel 1.16%) of GlaxoSmithKline GmbH & Co. KG, 80258, Munich, Germany in Patients with Osteoarthritis (OA) of the Knee.
Encube Ethical Private Limited, India21 个研究点 分布在 1 个国家目标入组 942 人开始时间: 2024年1月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 942
- 试验地点
- 21
- 主要终点
- Mean Change in the total WOMAC pain subscale score for the target knee.
研究概览
简要总结
The study is a Randomized, Double-Blind, Multicenter, Three-Arm, Placebo-Controlled, Parallel-Design, Bioequivalence Study with Clinical Endpoints comparing Diclofenac Diethylamine Gel 1.16% of Encube Ethicals Private Limited, India with Voltaren Schmerzgel 11.6 mg/g (Diclofenac Diethylamine Gel 1.16%) of GlaxoSmithKline GmbH & Co. KG, 80258, Munich, Germany in Patients with Osteoarthritis (OA) of the Knee.
The following are the main objectives of this clinical end-point bioequivalence study.
To evaluate bioequivalence (with clinical endpoints) of Diclofenac Diethylamine Gel 1.16% of
Encube Ethicals Private Limited, India with Voltaren Schmerzgel 11.6 mg/g (Diclofenac
Diethylamine Gel 1.16%) of GlaxoSmithKline GmbH & Co. KG, 80258, Munich, Germany in
Patients with Osteoarthritis (OA) of the Knee
To evaluate the superiority of two active treatments (Test and Reference) to the placebo in Patients with Osteoarthritis (OA) of the Knee
To assess the safety and tolerability of the study treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males or non-pregnant, non-lactating females aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology criteria, i.e. Knee pain along with at least 3 of the following 6 criteria (Appendix I) Age > 50 years Stiffness < 30 minutes Presence of crepitus Bony tenderness Bony enlargement No palpable warmth
- •Symptoms in the target knee for at least 6 months prior to screening
- •Knee pain for 15 days of the preceding month (periarticular knee pain due to osteoarthritis and not due to other conditions such as bursitis, tendonitis, etc.)
- •The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAID) 5.Patients having 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 (Appendix no.
- •II) Note: If a digital x-ray (both anterior-posterior and lateral view) of the target knee taken no more than 1 year before baseline is available then the findings of the available x-ray will be considered for evaluation and no repeat x-ray will be performed.
- •After discontinuation of all pain medications for at least 7 days (Placebo run-in period), have found at least moderate pain on movement (POM) for the target knee, defined as a baseline.
- •score of ≥ 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization (Appendix III)
- •After discontinuation of all pain medications for at least 7 days (Placebo run-in period), a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert, Version 3.1) pain subscale of ≥ 9 immediately prior to randomization (Appendix IV)
- •Able to replace all current pain medications with acetaminophen for use as needed during the duration of the study [subject should be able to withhold all rescue medication (e.g., acetaminophen) use for at least 48 hours prior to all WOMAC pain score assessments at study.
- •Change in the total WOMAC pain subscale score for the target knee ≤ 2 from Visit 2 (Start of Placebo Run-in period) to Visit 3 (Baseline/Randomization).
- •Subjects who can read and understand the WOMAC pain sub-scale.
- •Patients who are able to understand the investigational nature of this study and able to provide a written informed consent form
- •Patients who are willing and able to comply with all the study assessments and adhere to the protocol schedule
- •If female, the patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing the following methods of birth control: o Oral Contraceptives or Intrauterine Devices in place for at least 3 months prior to the start of the study and remaining in place during the study period, or o Double Barrier methods containing or used in conjunction with a spermicidal agent, or o Contraceptive Patches/ Implants, or o Abstinence: Subjects who will be practicing abstinence will agree to have a documented second acceptable method of birth control if the subject becomes sexually active during the course of her study participation.
排除标准
- •Known history or presence of hypersensitivity or allergic reaction to Diclofenac, aspirin, acetaminophen, or other NSAIDs, or any other inactive ingredients used in the study product
- •Females who are pregnant or lactating or planning to become pregnant during the study period
- •The X-ray confirmed Kellgren-Lawrence Grade 4 disease of Osteoarthritis
- •History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening
- •After discontinuation of all pain medications for at least 7 days (Placebo run-in period), had a baseline score of ≥ 20 mm on a 0-100 mm VAS for the contralateral knee immediately prior to randomization
- •History of OA of either Hip or Hands.
- •History or presence of secondary OA (e.g. Congenital, traumatic, gouty arthritis), rheumatoid arthritis
- •History or presence of chronic inflammatory disease (e.g. colitis) or fibromyalgia
- •Symptomatic peripheral vascular disease of the study leg (prior or current).
- •Any musculoskeletal condition that would impede measurement of efficacy at the target knee
- •History of regular headaches or backache or condition that warrants frequent use of acetaminophen (paracetamol) or NSAIDs within the previous year.
- •Concomitant skin disease at the application site may affect study drug application or tolerability evaluation.
- •History of active asthma within the previous year that may require periodic treatment with systemic steroids during the study period (note: inhaled steroids for this condition are allowed).
- •History of uncontrolled hypertension (blood pressure more than 150/100 mm of Hg) in spite of treatment within the previous year and/or any other clinically significant vital sign abnormality.
- •History of aspirin-sensitive asthma
- •History of myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function (Serum creatinine > 1.5 x ULN), or liver disease within 1 year of randomization
- •Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past month prior to entry into the study
- •Elevated transaminases (≥ 3 times ULN) and hemoglobin < 9.0 g/dL at screening
- •Concomitant use of intra-articular corticosteroids, systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening
- •Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (maximum 162 mg daily) was taken for at least 3 months prior to enrolment and maintained throughout the duration of the study.
- •History of major surgery or previous damage to the study knee at any time, or minor knee surgery (e.g. any surgery other than major surgery including, but not limited to, cartilage repair, collateral ligament repair, or arthroscopic debridement) to the study knee within 1 year prior to screening
- •Tense effusion requiring aspiration.
- •Known history of positive serology test i.e., HIV, HCV, or HBsAg
- •Involved in clinical trials and taken investigational drugs within 30 days of enrolment
- •Subjects with HbA1c ≥ 8 %
- •Subjects of any other severe acute or chronic medical conditions or abnormal laboratory findings, that may increase the risk in the participation of the study or could compromise the integrity of study data based on the judgment of the study Investigator.
- •History of alcohol or other substance abuse within the last year
- •Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.
- •Lives in the same household as currently enrolled subjects.
结局指标
主要结局
Mean Change in the total WOMAC pain subscale score for the target knee.
时间窗: Visit 3 (Baseline Visit) (Day 0), Visit 5 (End of Treatment Visit) (Day 28± 4)
次要结局
- Mean change in the total WOMAC pain subscale score for the target knee.
研究者
Dr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
研究点 (21)
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