CTIS2023-507370-41-00进行中（未招募）1 期
Randomized, controlled, open-label, multi-center trial to compare the efficacy and safety of three herbal medicinal products in the treatment of acute bronchitis - EA-20-01-032
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Acute bronchitis with symptoms that have been present for 48-72 hours prior to treatment, Male or female patients of any ethnic origin, Age: 18 – 75 years, inclusive, Patients who are able to understand and are willing to follow the study rules, Patients who have given their written informed consent to participate in the study, With the exception of the existing bronchitis, good state of health as judged by the investigator based on medical history and physical examination, CS score of at least 50 mm on the 100 mm VAS at visit V1, BSS of at least 10 points at visit V1, VCD score of at least 2 points at visit V1
排除标准
- •Allergic bronchial asthma, bronchial hyperresponsiveness, chronic bronchitis, other chronic or hereditary lung diseases, Any other phytopharmaceutical medication (e.g. pelargonium extracts or other ivy preparations) or homeopathic medicines for the common cold within the last 7 days before visit V1, Patients who have been strictly forbidden by their doctor to take minimal amounts of alcohol (e.g., after a detoxification cure), Medication, drug or alcohol abuse as judged by the investigator, Pregnant or lactating women, Body temperature >38.3°C, Women of childbearing potential who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1 of the clinical trial protocol; Definition of women of childbearing potential and post-menopausal women is given in chapter 4.2.8 of the clinical trial protocol.), Patients suffering from a significant condition, defined as a condition which, at the discretion of the investigator, either exposes the patient to a risk by participating in the study, or which affects the results of the study or the ability of the patient to participate in the study. This criterion includes patients with a history of gastrointestinal bleeding, significant cardiovascular, hepatic or renal disease., Patients directly or indirectly involved in the conduct of this study, including employees of the sponsor, CRO and their relatives, History of hypersensitivity to any of the constituents of the IMPs, History of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis or current hay fever, History of chronic gastritis or peptic ulcer, Any gastrointestinal complaints within the last 7 days before visit V1, Patients with known hereditary fructose-intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency, Participation in a clinical trial within the last 30 days prior to the treatment phase of this study, Simultaneous participation in another clinical trial with active ingredients, Treatment with corticoids, beta-2 agonists (e.g., salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g., Aspirin with daily dose > 100mg) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, ACE inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate within the last 7 days before visit V1
研究者
相似试验
招募中
3 期
Multicenter, randomized, controlled, open-label, phase-III clinical trial of PREoperative endoscopic injection of BOTulinum toxin in the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy (PREBOT trial)K86.8Other specified diseases of pancreasDRKS00010080Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial Director254
招募中
Unknown
Open-label, controlled, randomized, multicenter study to demonstrate the effect of the INKA digital therapy companion on symptoms of overactive bladder (with or without urinary incontinence).N32.8Other specified disorders of bladderDRKS00032952Dr. Pfleger Arzneimittel GmbH350
进行中（未招募）
不适用
on-blinded phase II study to compare the efficacy and safety of CetuGEX™ plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckstage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckMedDRA version: 14.1Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003695-13-ITGlycotope GmbH240
进行中（未招募）
1 期
on-blinded phase II study to compare the efficacy and safety of CetuGEX? plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckstage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckMedDRA version: 14.1Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003695-13-ESGlycotope GmbH240
进行中（未招募）
1 期
on-blinded phase II study to compare the efficacy and safety of CetuGEX™ plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckEUCTR2013-003695-13-PLGlycotope GmbH240