EUCTR2010-022441-21-AT进行中（未招募）不适用
EPs® 7630 film-coated tablets in subjects (=18 years old) suffering from common coldA prospective, multi-center, single-arm, open-label, phase IV clinical post-marketing safety study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •(1)Male and female subjects older or equal than 18 years old
- •(2)Written informed consent
- •(3)Subject suffers from common cold
- •(4)Presence of at least two common cold symptoms
- •(5)First common cold symptom started = 72 hours prior to inclusion into the study
- •(6)Subject with willingness and ability to comply with all procedures of the trial.
- •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
- •(1)Obstructive anatomic lesions in the nasopharynx such as nasal polyps, or severe septal deviations
- •(2)Previous surgery (within the last 12 months prior to inclusion into the study) or need for surgery of the nose or paranasal sinuses incl. sinus puncture
- •(3)Presence of any acute respiratory tract disease (e.g. tonsillitis, sinusitis, otitis media, bronchitis, pneumonia) other than common cold
- •(4)Subjects with known or suspected allergic rhinitis
- •(5)Subjects with other explanations of sore throat (e.g. tonsillo-pharyngitis, drugs, aphthous ulcers, candida, etc.)
- •(6)Subjects with previous rheumatic fever within the last 12 months prior to inclusion into the trial
- •(7)Subjects with several previous complications of tonsillitis (quinsy)
- •(8)Chronic lung diseases (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
- •(9)History of recurrent tonsillitis or otitis media of > 3 episodes during the last 12 months prior to enrolment into the study
- •(10)History of recurrent bronchitis of > 6 episodes during the past 12 months prior to enrolment into the study
- •(11)History of recurrent sinusitis of > 3 episodes during the past 12 months prior to enrolment into the trial or chronic sinusitis (symptoms lasting for > 1 month)
- •(12)Previous (within the last 6 weeks prior to inclusion into the clinical trial) or concomitant treatment with anti-coagulants
- •(13)Concomitant common cold medications that might impair the interpretation of trial results
- •(14)Known or suspected hypersensitivity to the investigational drug
- •(15)Severe cardiovascular disease, unstable diabetes mellitus, or immunosuppression
- •(16)History of renal or hepatic dysfunction (serum creatinine, serum AST, ALT or alkaline phosphatase of >3 times above the upper limit of normal values) at any time during the past 12 months prior to enrolment into the trial
- •(17)Known alcohol or drug abuse
- •(18)Subjects with tendency to bleed, especially nose or gingival bleeding
- •(19)Known gastrointestinal disorders (e.g. gastritis, duodenitis, colitis, gastric ulcer, partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhea)
- •(20)Females of child-bearing potential without adequate contraception
- •(21)Pregnancy or lactation
- •(22)Subjects participating in another clinical trial at the same time or have taken part in a clinical trial during the last 4 weeks before inclusion into this study
- •(23)Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
研究者
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