A Randomised Double Blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of 2 Doses of Ketoprofen Lysinate Lozenges (6.25 mg & 12.5 mg) in Patients With Sore Throat
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 801
- 试验地点
- 1
- 主要终点
- The TOTPAR15-120 which is the sum of each pain relief scale score
研究概览
简要总结
Primary Objective:
To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug.
Secondary Objectives:
To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on:
- the total pain relief summed over 15 to 360min (TOTPAR15-360)
- the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min.
- the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min
- the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3
To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on:
Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketoprofen lysinate 12.5 mg
干预措施: KETOPROFEN(RP19583) (Drug)
Ketoprofen lysinate 6.25 mg
干预措施: KETOPROFEN(RP19583) (Drug)
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The TOTPAR15-120 which is the sum of each pain relief scale score
时间窗: measured every 15 minutes during the 2 hours following the first study drug intake
次要结局
- The morning pain relief scale score(measured in morning of days 1, 2 and 3)
- The evening pain relief scale score(measured in evening of days 1, 2 and 3)
- The TOTPAR15-360 which is the sum of each pain relief scale score(Measured every 15 minutes during the 2 hours following the first study drug intake at study site then every hour up to 6 hours as outpatient.)
- The global throat pain intensity(assessed every 15 min during 2 hours after the first study drug intake)