Efficacy, safety and tolerability of Influcid tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms. A randomized, international, multicenter...

Update Il y a 4 ans
Reference: EUCTR2010-021422-35

Efficacy, safety and tolerability of Influcid tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms. A randomized, international, multicenter, controlled clinical trial

Woman and Man

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Extract

1. Fraction of patients with symptoms alleviation at day 4 of the study. Symptoms alleviation is defined as: - Absence of fever (axillary temperature ≤ 37.2°C) and - Absence or very mild degree of the symptoms assessed by Wisconsin Upper Respiratory Symptom Survey 21 (WURSS-21). Fever will be measured 3-times daily by the patient (or in case of children by their parents) at home. Mean value covering last 24 hours will be basis for this definition. Absence or very mild degree of symptoms is defined as answer to question “How sick do you feel today?” with “0” (not sick) or “1” (very mildly) for both assessments at day 4 (WURSS-21 is filled in twice daily by the patient or in case of children by their parents at home).


Inclusion criteria

  • Diagnosed upper respiratory tract infection (URTI) with presence of the following symptoms for equal or less than for 24 hours : a)Fever (axillary temperature >= 37.5°C) and b)At least one upper respiratory tract symptom: either i) one nasal symptom or ii) one pharyngeal symptom or iii) cough and c) at least one general symptom: either i) feeling tired or ii) weakness or iii) body aches or iv) for children only: irritable / whiny or less active

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