EUCTR2013-002977-23-AT进行中（未招募）1 期
Double-blind, randomised, placebo-controlled study evaluating the efficacy and Safety of Tavipec® capsules in acute RhinosinusitisA prospective, multi-centre, parallel group, interventional clinical phase IV study
Montavit Ges.m.b.H.0 个研究点开始时间: 2013年11月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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.Adult male and female outpatients aged = 18 - 75 years
- •2.Acute rhinosinusitis complying with following symptoms:
- •oRhinorrhea
- •oPostnasal drip
- •oNasal congestion/stuffiness
- •oSinus headache
- •oFacial pain
- •oReduction/loss of smell (hyposmie)
- •3.Sublingual temperature < 38.3°C, no dental involvement, impairment of general conditions.
- •4.Major Symptom Score (MSS) (> 5 but < 12)
- •5.ARS symptoms at enrolment do not exceed 3 days
- •6.Informed consent and willingness to comply with the protocol
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •-Signs or symptoms suggestive of acute bacterial rhinosinusitis (sublingual temperature >38.3°C, persistent severe unilateral facial or tooth pain, facial swelling, severe frontal or retroorbital pain radiating to the occiput) or of extrasinus manifestations, such as orbital cellulitis, dental or facial abscess, cavernous vein thrombosis
- •-Chronic recurrent rhinosinusitis with more than 4 episodes of acute rhinosinusitis per year and no complete resolution in-between
- •-Immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa
- •-Known or suspected hypersensitivity to the active substance and/or to any of the excipients
- •-Need for antibiotic treatment in patients at high risk of serious complications because of pre-existing comorbidity, including significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, human immunodeficiency virus infection, malignancy other than squamous or basal cell carcinoma of the skin
- •-Antibiotic therapy (local or systemic) at any time during the preceding four weeks
- •-Need for application of concomitant local medications including antibiotics, corticosteroids, antihistaminic agents
- •-Immunosuppressive therapy and/or systemic corticosteroids
- •-Systemic antihistaminic agents
- •-Radiation therapy or chemotherapy within the previous 12 months
- •-Pregnancy or lactating women
- •-History of alcohol or drug abuse likely to lead to uncooperative behavior
- •-History of psychiatric and/or neurological illness likely to lead to uncooperative behavior
- •-Participation in another clinical trial within 1 month
- •-Patients using medication for treatment of common cold like symptoms (excluding nasal douche)
研究者
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