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A double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of acetylsalicylic acid combined with pseudoephedrine, compared with acetylsalicylic acid alone, and pseud...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-011355-46

A double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of acetylsalicylic acid combined with pseudoephedrine, compared with acetylsalicylic acid alone, and pseudoephedrine alone, on symptoms of pain and nasal congestion in patients with symptomatic upper respiratory tract infection

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Extrait

The primary objective is to compare the efficacy of 1000 mg ASA combined with 60 mg PSE for pain and nasal congestion with 1000 mg ASA alone, 60 mg PSE alone and placebo in subjects with symptomatic common cold caused by acute URTI for the initial 4 hours after first dose. Efficacy on nasal congestion is assessed by nasal air flow (area under the nasal airflow conductance curve 0-4 hours post first dose - AUC0-4h) and pain is assessed by using a composite pain relief score (total pain relief score 0-4 hours post first dose - TOTPAR0-4h).

Critère d'inclusion

  • Nasal congestion and pain associated with viral upper respiratory tract infection

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