Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine

Inclusion Criteria:- Male and female subjects between 18 and 65 years of age.- Onset of
cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at
least moderate sore throat at baseline- Current complaint of at least moderate NC at
baseline- History of other symptoms associated with URTI during the last 4 days before
study participation.- Other findings of URTI, confirmed on the physical examination.-
Agreement to comply with the study requirements.- Written informed consent prior to
enrollment in the study Exclusion Criteria:- Pregnant or lactating females.- Uncontrolled
chronic diseases.- History of hypersensitivity (allergic reaction) to ASA, any other
nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.- Any disease which significantly
compromises breathing or interferes with the subjects assessment of sore throat.- History
of or active peptic ulcer.- Severe impaired hepatic function.- Severe impaired renal
function.- Simultaneous intake of monoamine oxidase inhibitors.- Use of menthol containing
tissues within 2 hours before first intake of study drug.- Intake of any menthol containing
product within 4 hours before first intake of study drug.- Use of any local or systemic
short acting cough and cold preparations within 6 hours before first intake of study drug.-
Use of any local or systemic long acting cough and cold preparations within 12 hours before
first intake of study drug.- Intake of any analgesic within 12 hours before first intake of
study drug.- Intake or requirement of any prescription medication for the treatment of the
current acute respiratory tract infection.- Current or previous intake of anticoagulants,
corticoids, NSAIDs, methotrexate, or lithium.- Participation in another clinical trial
within the last 30 days.