treatment of uncomplicated rhinal infections MedDRA version: 9.1 Level: LLT Classification code 10064948 Term: Viral rhinitis MedDRA version: 9.1 Level: LLT Classification code 10066743 Term: Acute rhinitis
Conditions
Interventions
Trade Name: Rhinoguttae pro Infantibus
Product Name: SILVER PROTEIN ACETYL TANNATE (SEAT) NOSE SPRAY 3%
Pharmaceutical Form: Nasal spray, solution
CAS Number: 9015514
Other descriptive name: SILVER PR
Sponsors
Leyh Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [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
Exclusion criteria
Exclusion criteria: [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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of the present trial is to investigate the safety of both preparations on the basis of safety clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/or adverse drug reactions.;Main Objective: The main objective in the present trial is to assess the efficacy and safety of a nasal preparation containing silver protein diacetyl tannate (SEAT) as 3% solution under double blind, placebo controlled conditions in patients with acute uncomplicated, viral rhinitis.;Primary end point(s): The primary endpoint in the present trial is the improvement from baseline of the viral rhinitis symptom score for the duration of 7 days of treatment. The improvement will be measured by the area under the symptom-score time curves over the 7 days of treatment (AUC) corrected for the baseline symptom score. The AUC will be calculated by the linear trapezoidal rule. This endpoint undergoes descriptive and comparative statistical evaluation. | — |
Countries
Bulgaria
Outcome results
None listed