CTRI/2026/01/100879尚未招募3 期
A Multicentric, Randomized, Double-blind, Parallel Group, Two Arm, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Etofenamate 10 percent w/w gel versus Diclofenac 1.16 percent w/w gel in patients with musculoskeletal pain
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 228
- 试验地点
- 12
研究概览
简要总结
Musculoskeletal pain is prevalent worldwide and greatly impacts the quality of life, social participation and economic burden. National & International Guidelines, Recommend to consider Topical NSAIDs and/or Paracetamol as first-line therapy ahead of Oral NSAIDs, COX-2 inhibitors or Opioids. Etofenamate is a Non-Steroidal Anti-Inflammatory Drug (NSAID). Etofenamate is not yet approved in India and this study is conducted to Evaluate the Efficacy, Safety and Tolerability of Etofenamate 10 % w/w gel versus Diclofenac 1.16 % w/w gel in patients with musculoskeletal pain
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
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Male or female subjects less than equal to 18 years to less than equal to 70 years both inclusive
- •Subject with any musculoskeletal pain
- •Subjects with at least moderate pain of less than equal to 4 to less than equal to 7 as measured by VAS.
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Women of childbearing potential if pregnant (test positive for pregnancy) at the screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •Subjects with known hypersensitivity to any component of study medication.
- •Subjects with painful musculoskeletal conditions, who need parenteral therapy/surgery/hospital admission for management.
- •Use of any other topical preparation at the application site.
- •Subjects with concomitant skin disease at the application site.
- •Any condition that, in the opinion of the Investigator, could affect study parameters.
- •Participation in another clinical trial within the past 30 days.
研究者
Dr Manjula S
Micro Labs Limited
研究点 (12)
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