EUCTR2019-004936-52-DE进行中（未招募）1 期
Prospective, controlled, randomized double-blind study to determine the sensory perception of two nasal sprays using the model of treatment of post-operative complaints after surgery on the nasal mucosa.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •- Signed and dated ICF
- •- Female or male patients between 18 and 64 years
- •- Non-pregnant, non-nursing women with adequate contraception
- •- Patients with post-operative nasal blockage following surgical interventions of the nasal cavity
- •- Surgical intervention must have been performed at least 1 week ago
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients who are simultaneously participating in other clinical trials or who have participated in a clinical trial within the previous 30 days prior to inclusion in the present trial
- •- Pregnancy, lactation, women without reliable contraception
- •- Patients in whom acute infections or epistaxis are detected by endoscopic examination of both nasal cavities
- •- Patients with a hypersensitivity (allergy) to the active ingredients xylometazoline hydrochloride or dexpanthenol and to the other components of nasic neo (sodium hyaluronate, potassium dihydrogen phosphate, sodium monohydrogen phosphate dodecahydrate) and nasic duo (potassium dihydrogen phosphate, disodium hydrogen phosphate)
- •- Patients with dry inflammation of the nasal mucosa (rhinitis sicca)
- •- Patients undergoing surgical removal of the pituitary gland through the nose (transphenoidal hypophysectomy) or other surgical procedures that expose the dura mater
- •- Patients treated with monoamine oxidase (MAO) inhibitors and other potentially hypertensive drugs
- •- Patients treated with alpha inhibitors (e.g. Prazosin, Tamsulosin, Urapidil etc)
- •- Patients with increased intraocular pressure, especially glaucoma (narrow angle glaucoma)
- •- Patients with severe cardiovascular diseases (e.g. coronary heart disease, hypertension and long QT syndrome)
- •- Patients with a tumor of the adrenal gland (pheochromocytoma)
- •- Patients with metabolic disorders, such as hyperthyroidism and diabetes mellitus
- •- Patients with the metabolic disease porphyria
- •- Patients with prostate enlargement (prostate hyperplasia)
- •- Addiction to alcohol or drug
- •- Insufficient knowledge of the national language, which endangers the compliance with the regulations
研究者
相似试验
已完成
不适用
Prospective, double-blind, randomized controlled trial on efficacy of lidocaine injection method during esophageal endoscopic submucosal dissection.early esophageal cancerJPRN-UMIN000032804Saiseikai Nakatsu Hospital50
进行中（未招募）
不适用
The goal of the study is to improve the patients prognostif by decreasing perioperative blood losses thanks to two new colloidal solutions (last generation starches extracted from corn or potato) and thanks to an optimisation of the vascular filling by a low invasive monitoring: the vigileo.Elective cardiac surgeryEUCTR2011-005920-16-BEAssociation Hospitalière CHU Brugmann
进行中（未招募）
1 期
Efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumoniasevere COVID-19 pneumonia requires invasive ventillatory supportMedDRA version: 23.1Level: LLTClassification code 10084564Term: SARS-CoV-2 pneumoniaSystem Organ Class: 100000004862EUCTR2021-001665-20-HUSemmelweis University Department of Oralbiology200
进行中（未招募）
1 期
Controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgeryEUCTR2016-002162-30-BEFresenius Kabi Deutschland GmbH2,280
尚未招募
不适用
Prospective, randomized, controlled, double-blind clinical study of traditional Chinese medicine combined with glucocorticoid in the treatment of generalized myasthenia gravisMyasthenia GravisITMCTR2100005054Zhejiang Provincial Hospital of Traditional Chinese Medicine