跳至主要内容
临床试验/CTRI/2026/01/100879
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

Micro Labs Limited12 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2026年2月5日最近更新:

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

申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Manjula S

Micro Labs Limited

研究点 (12)

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