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临床试验/NCT00810121
NCT00810121已完成3 期

Non-inferiority Study of Bi-Profenid® 200 mg Versus Bi-Profenid® 300 mg in Patients Presenting With Pain Related to Closed, Benign, Acute Post-traumatic Conditions of the Motor System or Acute, Non-infectious Rheumatologic Conditions

Sanofi1 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Sanofi
入组人数
409
试验地点
1
主要终点
Resting pain intensity measured using the numeric scale (NS) at the end of the day, and total intake of concomitant analgesics over 5 days. For these two parameters, the maximum value will be assigned to patients who used step II or III analgesics

研究概览

简要总结

Primary objective:

To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics.

Secondary Objectives:

  • To describe concomitant analgesic treatments
  • To describe the time between baseline and use of a step I, II or III analgesic
  • To evaluate patients pain relief using a Likert 4-class scale (complete or substantial relief, moderate relief slight relief and absence of relief) at D5
  • To evaluate changes in intensity of pain when moving, over the entire day, measured at the end of the day using a numeric scale, over 5 days
  • To evaluate the patients overall satisfaction at the end of treatment using a 4-point Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
  • To evaluate the patients overall satisfaction at the end of the study using a 4-point Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
  • To compare the safety of the two treatments

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

2

Experimental

Ketoprofen 150 mg b.i.d. for 5 days

干预措施: ketoprofen (Drug)

1

Experimental

Ketoprofen 100 mg b.i.d. for 5 days

干预措施: ketoprofen 100 mg (Drug)

结局指标

主要结局

Resting pain intensity measured using the numeric scale (NS) at the end of the day, and total intake of concomitant analgesics over 5 days. For these two parameters, the maximum value will be assigned to patients who used step II or III analgesics

时间窗: between D1 and D5, at the end of the day

次要结局

未报告次要终点

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (1)

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