EUCTR2013-002970-32-SI进行中（未招募）1 期
A COMPARISON OF THERAPEUTIC EQUIVALENCE BETWEEN THE TEST AND THE REFERENCE FORMULATION OF FIXED COMBINATION OF CETYLPYRIDINIUM CHLORIDE 1.0 mg/BENZYDAMINE HYDROCHLORIDE 3 mg IN SUBJECTS WITH SORE THROAT ASSOCIATED WITH UPPER RESPIRATORY TRACT INFECTIONS
KRKA, tovarna zdravil, d. d., Novo mesto0 个研究点目标入组 340 人开始时间: 2013年11月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
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
- •Subjects with a sore throat associated with upper respiratory trat infection
- •Onset of sore throat = 6 days
- •Both sexes, age range 18-65 years
- •= 4 points on the 10 point Tonsillopharyngitis assessment (TPA) score
- •Moderate to severe sore throat pain defined as a score = 60 mm on
- •the 100 mm Sore Throat Pain Intensity Scale
- •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 340
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 340
排除标准
- •Pregnancy or lactation or unreliable contraceptive method
- •Subjects with any evidence of mouth breathing or coughing which could compromise respiratory function and worsen sore throat
- •Severe streptococcal tonsillitis assessed by rapid antigen detection test (RADT)
- •Increased body temperature that needs antipyretic treatment (more than 38.5 C)
- •Recurrent (chronic) sore throat
- •Other severe respiratory tract diseases (pneumonia, infectious mononucleosis, asthma or difficulty in breathing, peritonsillar abscess etc.)
- •Oropharyngeal lesions (tumours, purulent necrotic process, aphtous ulcers, etc.)
- •Pharmacological therapy with:
- •-Antibiotics currently,
- •-oral antiseptics and demulcents in the form of sprays, gargles, lozenges or drops within 3 h before the initial dose,
- •-short-acting analgesics within 6 hours before the initial dose,
- •-long-acting or slow-release analgesic within 24 hours before the initial dose,
- •-local anaesthetics within 4 hours before the initial dose,
- •-antihistamines within 12 hours before the initial dose,
- •-nasal decongestants, anti-tussives or expectorants including their fixed combinations within 8 hours before the initial dose.
- •Any chronic disease which requires long-term use of oral analgesics, NSAIDs, antihistamines and local anaesthetics
- •Previously diagnosed hypersensitivity to benzydamine, other NSAIDs, cetylpyridinium chloride or any other component of study drugs including the rescue medication (paracetamol)
- •Subject is currently participating in another clinical trial
- •Excessive alcohol consumption, drug abuse or drug addiction
- •Subject refuses to participate with the investigator
研究者
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