CTRI/2010/091/001495已完成3 期
A Phase III, Three Arm, Double Blind, Randomized, Multi-centric, Comparative Superiority Study To Evaluate The Efficacy And Safety Of A Fixed Dose Combination (Naproxen 500mg + Paracetamol 500mg) In Comparison With Naproxen 500mg Or Paracetamol 500mg Given Alone For Short Term Management Of Acute Painful/Inflammatory Conditions
RPG Life Science LTD, Ceat amhal, Dr annie Besant Road, worli Mumbai 4000030. Telephone; +91 22 249816500 个研究点目标入组 210 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
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
- •?Male and Female patients of above 18 years and upto below 70 years of age.
- •?Patients with acute painful condition for a month or less.
- •?Patients with mild to moderate pain due to acute painful/inflammatory condition e.g. acute musculoskeletal pain, dysmenorrhoea, acute back pain, acute joint pain and dental pain)
- •?Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •?Male and Female patients < 18 years and > 70 years of age.
- •?Current pregnancy or lactation amongst females.
- •?History of or preexisting Hematological, Renal, Cardiac or Hepatic disease.
- •?History of hypersensitivity to NSAIDs / Paracetamol.
- •?Patients with Bronchial Asthma, Recurrent Rhinitis, Nasal Polyps.
- •?History of hypersensitivity to Aspirin.
- •?Patients with history of any of the following conditions within a period of 3 months prior to screening:
- •oActive esophageal and/or gastric or duodenal ulcer
- •oGastrointestinal bleeding
- •oCrohn?s disease
- •oUlcerative colitis
- •oChronic diarrhea
- •?Patients who have participated in any other clinical trial in the past 90 days.
研究者
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