CTRI/2023/01/049202进行中（未招募）3 期
on-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
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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).
- •2. Injury that has led to sprain/strain should have occurred within 24 h before
- •3. 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.
- •4. Able to understand the requirements of the clinical trial and to agree to return
- •for the required follow-up visits.
- •5. Willing to provide voluntary written informed consent and data protection
- •declaration before any clinical trial related procedure is performed.
排除标准
- •1. Ligament rupture or severe sprain not considered amenable to treatment with
- •topical NSAIDS alone.
- •2. Open skin lesion in the injured area
- •3. Clinical evidence of fracture
- •4. Dermatological conditions, such as eczema or skin infections on the injured
- •5. Use of medication (other than the study drugs) for the treatment of complaints caused by the affected area
- •6. Other inflammatory or painful conditions (e.g. headache, toothache).
- •7. Similar injury of the same area within the last 3 months
- •8. Debilitating acute/chronic illness,
- •9. 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).
- •10. Use of Systemic corticosteroid or immunosuppressive drugs in the previous 8
- •11. Pregnant or lactating or planning to become pregnant during the study period.
- •12. Patients with or without chronic asthma in whom attacks of asthma, urticaria, or
- •acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti inflammatory agents
- •13. History of OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis)
- •or fibromyalgia.
- •14. History of asthma, hypertension, myocardial infarction, thrombotic events,
- •stroke, congestive heart failure, impaired renal function or liver disease.
- •15. History of gastrointestinal bleeding or peptic ulcer disease.
- •16. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- •17. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or
- •methotrexate within the past month prior to entry into the study.
- •18. Women of child-bearing age who are not surgically incapable of pregnancy and
- •are unwilling to use an acceptable method of birth control.
- •19. Current participation or not yet completed period of at least 30 days since
- •ending other investigational device or drug trial(s);
- •20. Unwillingness or inability to comply with the clinical trial procedures.
- •21. Unwillingness to consent to storage, saving and transmission of pseudonymous
- •medical data for clinical trial reasons.
- •22. Patients who are deemed to be legally incapacitated.
- •23. Patients who are legally detained in an official institute.
研究者
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