The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
833
2 Sachets of 500 mg Aspirin Complex.
2 Sachets of 30 mg Pseudoephedrine
Matching Placebo
Unnamed facility
Cardiff, South Glamorgan, United Kingdom
Reduction of nasal congestion and relief of pain
Time frame: 4 hours
Area under the curve for nasal airflow conductance from baseline
Time frame: 1h, 2h, 3h
Sum of subjective nasal congestion intensity differences
Time frame: 1h, 2h, 3h, 4h and 1, 2, 3 days
Total subjective nasal congestion relief
Time frame: 1h, 2h, 3h,4 h and 1, 2, 3 days
Global assessment of nasal congestion
Time frame: 3 days
Global assessment of pain relief
Time frame: 3 days
Sum of pain intensity differences
Time frame: 1h, 2h, 3h, 4h and 1, 2, 3 days
Total pain relief
Time frame: 1, 2, 3 days
Adverse Event collection and physical examination
Time frame: 3 days
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