ISRCTN65790556已完成4 期
EPs® 7630 film-coated tablets in subjects (greater than or equal to 18 years old) suffering from common cold: a prospective, multicentre, single-arm, open-label, phase IV clinical post-marketing safety study
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 120 人开始时间: 2011年1月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
2021 results in https://pubmed.ncbi.nlm.nih.gov/33995094/ (added 18/05/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects aged greater than or equal to 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 less than or equal to 72 hours prior to inclusion into the study
- •6. Subject with willingness and ability to comply with all procedures of the trial
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 including 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 greater than 3 episodes during the last 12 months prior to enrolment into the study
- •10. History of recurrent bronchitis of greater than 6 episodes during the past 12 months prior to enrolment into the study
- •11. History of recurrent sinusitis of greater than 3 episodes during the past 12 months prior to enrolment into the trial or chronic sinusitis (symptoms lasting for greater than 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 aspartate aminotransferase [AST], alanine aminotransferase [ALT] or alkaline phosphatase of greater than 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, coeliac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
- •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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