EUCTR2008-008265-36-FR进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of two doses of ketoprofen (as lysinate) lozenges (6.25mg and 12.5mg ) in patients with sore throat” - KRYSTA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 835
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Male or female patients aged 18 or over,
- •?Patients with a sore throat associated or not with a URTI = 24 hours and = 6 days’ duration, in the absence of A.Streptococcus*,
- •?Evidence of tonsillo- pharyngitis (TPA score = 5) at inclusion,
- •?With a score of throat soreness = 6 (0-10 ordinal scale),
- •?With a perception of swollen throat = 60mm (VAS),
- •?With a global throat pain intensity such as pain at swallowing
- •?assessed by a VAS = 60 mm,
- •?Informed consent obtained in writing at the enrolment into the study,
- •?Ability to understand and comply with study protocol.
- •*Specific exploration at Inclusion:
- •- The Score of Mac Isaac will be performed by the investigator.
- •- Presence of streptococcus will be assessed by a throat swab test
- •Patients having a positive swab test will not be included.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Active gastric or duodenal ulcer
- •?Severe liver disease
- •?Severe kidney disease
- •?Women known to be pregnant
- •?Breastfeeding women
- •?Any oral surgery or dental extraction within one week prior to the inclusion and during study treatment
- •?Any oropharyngeal acute disease that needs an intervention without any delay.
- •?Any mouth ulcer, gingivitis or periodontitis with a high risk of haemorrages
- •?Any patients having participated to this or another clinical trial within the previous 30 days.
- •?Patients having used any local medication containing a local oral anesthetic such as lozenge, spray, mouth rinse or any topical throat treatment within 2 hours before study entry
- •?Patients with positive throat swab test for A.Streptococcus pharyngitis
- •?Patients having used analgesics within 4 hours before study entry
- •?Patients having used any long-acting or slow release analgesics within 12 hours before study entry
- •?Patients having used any anti inflammatory treatment 8-12 hours before study entry
- •?Patients having used any anti histaminic 8-12 hours before study entry
- •?Patients with pharyngeal paresthesia
- •?Patients with pharyngeal mycosis
- •?Patients with known history of ketoprofen, aspirin or other NSAID-induced bronchospasm
- •?Hypersensitivity to ketoprofen or its excipients
- •?Any disease that could compromise breathing such as bronchopneumonia or asthma
- •?Evidence of mouth-breathing or uncomfortable coughing
- •?Any chronic disease that requires a long period anti-inflammatory treatment
- •?Any chronic disease that requires long term use of anticoagulants or use of anticoagulants or anti-platelet agents one week before study entry
研究者
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