EUCTR2006-005461-19-CZ进行中（未招募）1 期
A Randomized, Double Blind, Placebo Controlled Multicenter Study to Assess the Tolerability and Safety of ANTIRIN® nasal spray and drops in two Age Groups of Children with Acute Rhinitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Zentiva a.s.
- 入组人数
- 240
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
- •To participate in this trial, patients will have to meet all of the following criteria:
- •established diagnosis of acute rhinitis. All following criteria must be met:
- •othe occurrence of two nasal symptoms at least: congestion, rhinorrhea, mucosa burning or itching, sneezing
- •oduration of nasal symptoms = 30 days
- •no topical decongestives during last 7 days
- •patients between 2 – 7 years, both genders ……Group I
- •patients between 8 – 18 years, both genders ……Group II
- •written informed consent obtained of patient s guardian and patient (if possible)
- •good collaboration with parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria will be excluded from participation in this study:
- •Rhinitis which originated before more than 30 days
- •Rhinitis medicamentosa
- •Rhinitis sicca
- •Otitis media
- •patients with unstable bronchial asthma
- •patients with unstable endocrine disease
- •patients with the history of narrow angle glaucoma
- •patients with history of hypersensitivity to the study drug or its excipients
- •patients taking the following drugs:
- •othe need of administration of local (nasal) corticosteroid drugs
- •ouse of any other nasal decongestant drugs orally or locally ( e.g. intransally) within 7 days prior inclusion
- •oSystemic corticosteroids: changes in dose within 7 days prior inclusion
- •oAntihistamin drugs: changes in dose within 7 days prior inclusion
- •oantihypertensive drugs that may influence nasal congestion within 7 days prior inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin)
- •oMAO inhibitors and other drugs with hypertensive potential within 14 days prior inclusion.
- •patients with the history of nasal polyps
- •patients with major nasal septum deviation
- •any other disease or condition which may interfere with study assessments as judged by the investigator
- •patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months
- •clinically significant renal/hepatic impairment or serious heartdisease and uncontrolled hypertension
- •patients with pheochromocytoma
- •patients presenting any malignant disease
- •patients likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator
研究者
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