E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
treatment of uncomplicated rhinal infections |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064948 |
E.1.2 | Term | Viral rhinitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066743 |
E.1.2 | Term | Acute rhinitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial (last visit) is after 7 days of treatement. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |