EUCTR2007-005797-31-BG进行中（未招募）不适用
Efficacy and tolerability of EPs® 7630 film-coated tablets in patients (>=18 years old) with Acute Rhinopharyngitis (ARP)
适应症
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 patients >=18 years old
- •(2)Written informed consent
- •(3)Patients suffering from acute rhinopharyngitis (ARP)
- •(4)Presence of
- •(a)both major rhinopharyngitis-relevant symptoms (RPS) (nasal discharge and sore throat) with >= 2 points each and at least two minor RPS (nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, or fever) with >= 2 points each, or
- •(b)one major RPS with >= 2 points and at least three minor RPS with >= 2 points each
- •(5)Start of the acute rhinopharyngitis-relevant symptoms (RPS) 24-72 hours prior to inclusion into the study
- •(6)Patients with willingness and ability to comply with all procedures of the trial and attend all scheduled visits at the investigational site
- •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 ENT diseases other than rhinopharyngitis and/or presence of respiratory tract disease (e.g. tonsillitis, sinusitis, otitis, bronchitis, pneumonia)
- •(4)Patients with allergic rhinitis
- •(5)Chronic lung diseases (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
- •(6)Recurrent tonsillitis or otitis of > 3 episodes during the last 12 months prior to enrolment into the study
- •(7)Recurrent bronchitis of > 6 episodes during the past 12 months prior to enrolment into the study
- •(8)Recurrent sinusitis of > 3 episodes during the past 12 months prior to enrolment into the trial or chronic sinusitis (symptoms lasting for > 1 month)
- •(9)Previous treatment with antibiotics, glucocorticosteroids or antihistamines within the last 4 weeks prior to enrolment into the trial
- •(10)Previous (within the last 6 weeks prior to inclusion into the clinical trial) or concomitant treatment with anti-coagulants
- •(11)Previous treatment with cold medications (e.g. decongestants, local anesthetics, zinc, Echinacea, vitamin C >=100 mg per day), anti-inflammatories, anti-tussiva, mucolytics, secretolytics, Pelargonium sidoides preparations, herbal treatment for cold, or pain relief medications (e.g. aspirin, paracetamol) within the last 7 days prior to enrolment into the trial
- •(12)Concomitant medications that might impair the interpretation of trial results (e.g. antibiotics, glucocorticosteroids, antihistamines, any cold medications such as decongestants, zinc, Echinacea, vitamin C >= 100 mg per day , anti-inflammatories, secretolytics, anti-tussiva, mucolytics, herbal medications for respiratory tract infection other than the study medication, or pain relief medications other than paracetamol)
- •(13)Known or suspected hypersensitivity to the investigational drug
- •(14)Severe cardiovascular disease, unstable diabetes mellitus, or immunosuppression
- •(15)Known severe renal or hepatic dysfunction (serum creatinine, serum AST, ALT or alkaline phosphatase >3 times above the upper limit of normal values) at any time during the past 12 months prior to enrolment into the trial
- •(16)Significant symptoms within the last 6 months prior to enrolment into the study, e.g. un-unintentional weight loss, or any other sign indicating serious or malignant disease
- •(17)Evidence of any malignant disease during the past 5 years prior to enrolment into the trial
- •(18)Heavy smoking (= 25 cigarettes per day)
- •(19)Intake of >= 500 mg caffeine per day
- •(20)Known alcohol or drug abuse
- •(21)Patients with tendency to bleed, specially nose or gingival bleeding
- •(22)Known gastrointestinal disorders (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhea)
- •(23)Females of child-bearing potential with no adequate contraception
- •(24)Pregnancy or lactation
- •(25)Patients 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
- •(26)Irresponsible patients or those unable to understand nature, meaning and consequences of the trial
研究者
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