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临床试验/EUCTR2013-002977-23-PL
EUCTR2013-002977-23-PL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 个研究点目标入组 320 人开始时间: 2014年8月14日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
320
研究概览入排标准研究者记录与标识符相似试验

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 200
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 120
  • •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 200
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 120
  • •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:
  • 另有 4 项未显示

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)
  • •-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)
  • •-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

发起方
Montavit Ges.m.b.H.

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