Non-inferiority, Randomized, Double- blind Clinical Trial for Comparing the Efficacy and Tolerability of Diclofenac diethylamine 1.16% w/w gel of JAMP Pharma vs Voltaren Emulgel® (Diclofenac diethylamine 1.16% w/w) of GlaxoSmithKline Consumer Healthcare Inc., Canada in Patients with acute localized muscle or joint injuries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 10
- 主要终点
- To confirm the clinical non-inferiority of the generic Diclofenac diethylamine 1.16% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel/GSK (Reference) in patients with acute localized muscle or joint injuries on relief of pain as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0–100) after seven days of treatment
研究概览
简要总结
This study is Non-inferiority, Randomized, Double blind, Clinical Trial for Comparing the Efficacy and Tolerability of Diclofenac diethylamine 1.16% w/w gel of JAMP Pharma vs Voltaren Emulgel® (Diclofenac diethylamine 1.16% w/w) of GlaxoSmithKline Consumer Healthcare Inc., Canada in Patients with acute localized muscle or jointinjuries. Sample size is 255: 102 patients for Test, 102 for Reference and 51 for Placebo, where the primary objective is to confirm the clinical non-inferiority of the generic Diclofenac diethylamine 1.16% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel/GSK (Reference) in patients with acute localized muscle or joint injuries on relief of pain as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0–100) after seven days of treatment and secondary objective is to confirm the superiority of Test and Reference to Placebo in pain after seven days of treatment, to estimate the relief of pain of Test product compared to Reference during the treatment period and to demonstrate the tolerability of Test and Reference products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed by physical examination with acute strains Grade I and II (as classified by the American Medicine Association system) or sprains Grade I and II (as classified by The West Point Ankle Grading System).
- •Injury that has led to sprain/strain should have occurred within 24 h before enrolment
- •Pain on movement of injured area [measured on a 100 mm visual analogue scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain)] ≥ 35 mm immediately prior to randomization.
- •Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits.
- •Willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
排除标准
- •Ligament rupture or severe sprain not considered amenable to treatment with topical NSAIDS alone.
- •Open skin lesion in the injured area
- •Clinical evidence of fracture
- •Dermatological conditions, such as eczema or skin infections on the injured area
- •Use of medication (other than the study drugs) for the treatment of complaints caused by the affected area
- •Other inflammatory or painful conditions (e.g. headache, toothache).
- •Similar injury of the same area within the last 3 months
- •Debilitating acute/chronic illness,
- •Use of long-acting NSAIDs, cyclooxygenase (COX)-2 inhibitors or tramadol in the previous 24 h; any other analgesics in the previous 6 h; use of any other topical products applied to the target site (Treatment by rest, ice, compression, or elevation prior to randomization is allowed).
- •Pregnant or lactating or planning to become pregnant during the study period.
- •Patients with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal antiinflammatory agents
- •History of OA, rheumatoid arthritis, chronic inflammatory disease (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 gastrointestinal bleeding or peptic ulcer disease.
- •Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- •Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past month prior to entry into the study.
- •Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
- •Unwillingness or inability to comply with the clinical trial procedures.
- •Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons.
- •Patients who are deemed to be legally incapacitated.
结局指标
主要结局
To confirm the clinical non-inferiority of the generic Diclofenac diethylamine 1.16% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel/GSK (Reference) in patients with acute localized muscle or joint injuries on relief of pain as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0–100) after seven days of treatment
时间窗: Day 0 (Baseline) & Day 7 (End of treatment)
次要结局
- •Mean change in VAS of pain on movement of injured area from baseline Day 0 to Day 3, baseline Day 0 to Day 5.(•Proportion of patients with reduction in VAS of pain on movement of injured area, Mean change in VAS of pain at rest, Proportion of patients with reduction in VAS of pain at rest, Mean change of normal function/activity of the injured area, Proportion of patient with improvement in normal function/activity of the injured area, Mean change of passive joint mobility in patients with sprains, Proportion of patient with improvement in passive joint mobility in patients with sprains from baseline Day 0 to Day 7, baseline Day 0 to Day 3 and baseline-Day 0 to Day 5.)