Evaluation of the efficacy and safety of nose spray containing 3% silver protein diacetyl tannate (SEAT) in patients with uncomplicated viral rhinitis. A placebo-controlled, randomized, multicentric Phase III trial.
- Conditions
- treatment of uncomplicated rhinal infectionsMedDRA version: 9.1Level: LLTClassification code 10064948Term: Viral rhinitisMedDRA version: 9.1Level: LLTClassification code 10066743Term: Acute rhinitis
- Registration Number
- EUCTR2008-005442-23-BG
- Lead Sponsor
- eyh Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
[1]patients with uncomplicated viral rhinitis
[2]rating of rhinitis symptoms by investigator of at least moderate” at baseline
[3]age between 18 and 55 years
[4]informed consent given in written form according to chapter 125H5.4 of study 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
[1]duration of current common cold symptoms of more than 48 hours
[2]diagnosis of any other infectious disease that produces also symptoms of common cold but needs specific treatment with antibacterial or antiviral drugs (e.g. bronchitis, pneumonia etc.)
[3]any other concomitant drug treatment of symptoms of common cold
[4]any concomitant physical therapy of symptoms of common cold
[5]changes in existing concomitant therapy with corticosteroids, or other drugs with influence on the immune system (e.g. immunosuppressive or cytostatic agents)
[6]participation in another clinical trial at same time or within the preceding 3 months except for previous bioequivalence trials in which case at least 8 weeks are sufficient
[7]history of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year of screening
[8]alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
[9]allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity or allergic rhinitis)
[10]any history of drug hypersensitivity (especially to the active and inactive ingredients of the silver protein diacetyl tannate preparation)
[11]severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety
[12]pregnancy or lactation period
[13]legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
[14]evidence of an uncooperative attitude.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method