NCT01785862已完成3 期
Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 427
- 主要终点
- Total Pain relief over 2 hours
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from 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
- 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
- •male or female aged at least 18 years old
- •patient with an acute sore throat
排除标准
- •Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- •Oro-pharyngeal paresthesia or mycosis
- •Severely traumatised and/or very severe oromucosal inflammation
- •Tonsillopharyngectomy
- •Peritonsillar abscess
- •Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients
- •Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
- •Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
- •Any paracetamol intake within 6 hours before randomisation
- •Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
- •Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
- •Heavy smokers (>20 cigarettes/day)
研究组 & 干预措施
Drug
Experimental
V0498, Ibuprofen 25 mg
干预措施: Ibuprofen 25 mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Total Pain relief over 2 hours
时间窗: 0-2 hours post-dose
Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered
次要结局
未报告次要终点
研究者
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