NCT01535079已完成2 期
Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Change from baseline of Sore Throat Pain Intensity Scale
研究概览
简要总结
"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature.
The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."
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
- Triple (Participant, 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
- •male or female patients 18 years and older
- •patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A
排除标准
- •patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
- •patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
- •patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry
- •patients having taken antibiotics within 14 days before study entry.
研究组 & 干预措施
V0498TA01A 15 mg
Experimental
干预措施: Ibuprofen 15 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
V0498TA01A 25 mg
Experimental
干预措施: Ibuprofen 25 mg (Drug)
V0498TA01A 35 mg
Experimental
干预措施: Ibuprofen 35 mg (Drug)
Strefen
Other
Positive control
干预措施: Strefen (Drug)
结局指标
主要结局
Change from baseline of Sore Throat Pain Intensity Scale
时间窗: 60 minutes
次要结局
- Change from baseline of Sore Throat Pain relief Scale(up to 360 minutes)
- Change of Sore Throat Pain Intensity Scales(up to 360 minutes)
- Local tolerability examination(Baseline (before drug intake) and 360 minutes)
- General tolerability (reported adverse events)(Baseline (before drug intake) and 360 minutes)
研究者
研究点 (2)
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