CTRI/2010/091/003050已完成3 期
A randomized, two arm, open label, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical solution of diclofenac (4.64% w/v) in comparison with diclofenac topical gel (1.16% w/w) in acute painful musculoskeletal conditions.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
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. Male or females patients aged 18- 70 years.
- •2.Patients with acute low back ache (non- specific) or pain and inflammation following trauma to muscles/ tendons/ ligaments/ joints (due to strains, sprains, stress, soft tissue injuries or blunt sports injuries) for not more than 2 days
- •3.Patients with at least moderate pain of VAS ≥ 4
排除标准
- •1.Patients below 18 years or above 70 years of age.
- •2.Hypersensitivity to aspirin/ NSAID or any other component of the formulation
- •3.Any contraindication to diclofenac / NSAIDs
- •4.Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application
- •5.Concomitant skin disease at site of application
- •6.Use of another topical product at application site
- •7.Pregnant women and lactating mothers
- •8.Women of child bearing age not practicing or not willing to use contraceptive
- •9. Patients already on oral NSAIDs/ analgesics
- •10. Patients requiring hospitalization or other treatment for pain
研究者
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