The purpose of this study is to investigate the analgesic efficacy of a single dose of a fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult patients with sore throat associated with a common cold in comparison to a single treatment with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to provide relief from sore throat pain by sequential action. A very fast inset of action will be achieved by the locally acting Lidocaine and a long duration of action will be achieved by the systemically acting Aspirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,088
Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)
Single oral application of Aspirin (as lozenge)
Single oral application of Lidocain (as lozenge)
Single oral application of Placebo (as lozenge)
Unnamed facility
Mocow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
...and 9 more locations
Sum of pain intensity differences SPID
Time frame: 120 minutes
Pain intensity difference to baseline (PID12 min)
Time frame: 12 minutes
Pain intensity difference to baseline (PID120 min)
Time frame: 120 minutes
Pain intensity difference to baseline (PID)
Time frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Total pain relief to baseline (TOTPAR)
Time frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)
Time frame: 60, 120, 180, and 240 minutes post dose
Overall assessment of treatment
Time frame: 240 minutes
Assessment of safety and tolerability
Time frame: 240 minutes
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