跳至主要内容
临床试验/CTRI/2010/091/000076
CTRI/2010/091/000076已完成3 期

A Randomized, Two Arm, Open Label, Comparative, Clinical Study to evaluate efficacy and safety of a fixed dose combination of diclofenac 25mg + paracetamol 325mg given TID versus Aceclofenac 100mg given BD in patients with osteoarthritis.

Troikaa Pharmaceuticals Limited0 个研究点目标入组 150 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
150

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 45-80 years.
  • 2 Patients with a working diagnosis of osteoarthritis as defined by
  • NICE 2008 guidelines (Appendix-II)
  • 3. At least moderate pain within past 2 weeks

排除标准

  • 1. Secondary osteoarthritis related to syphilis, metabolic bone disorder, acute trauma
  • 2. Hypersensitivity to aspirin/ NSAID or any other component of the formulation
  • 3. Any contra-indication to either medication.
  • 4. Clinically active hepatic or peptic ulcer disease
  • 5. H/O alcohol or drug abuse
  • 6. Clinically significant impairment of hepatic and renal functions
  • 7. Corticosteroid use
  • 8. Use of any other analgesic or glucosamine
  • 9. Baseline laboratory values outside the clinically acceptable limits
  • 10. Pregnant women and lactating mothers
  • 11. Women of child bearing age not practicing or not willing to use contraceptive
  • 12. Patients or relatives unwilling to give written informed consent
  • 13. Participation in a clinical study involving an investigational product within past 120 days.

研究者

相似试验