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Acetylsalicylic acid & Lidocain · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Arm 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain | DRUG | Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge) |
| Acetylsalicylic Acid (Aspirin, BAYE4465) | DRUG | Single oral application of Aspirin (as lozenge) |
| Lidocain | DRUG | Single oral application of Lidocain (as lozenge) |
| Placebo | DRUG | Single oral application of Placebo (as lozenge) |
Inclusion Criteria: * Males and females of at least 18 years of age * Onset of common cold within the last 3 days (12 to 72 hours) * History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullne...
Acetylsalicylic acid & lidocaine is an investigational combination developed for the symptomatic treatment of sore throat associated with the common cold, including pharyngitis and tonsillitis. It is formulated as a lozenge and is being studied in adults 18 years and older. It is not approved for this use.
Bayer AG is developing acetylsalicylic acid & lidocaine. Bayer AG trades on the OTC market under the ticker BAYRY. The company sponsored the clinical program evaluating the combination lozenge for sore throat associated with the common cold.
Acetylsalicylic acid & lidocaine is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational and has not been approved by the FDA for any indication.
Acetylsalicylic acid & lidocaine has been studied in one completed Phase 3 trial, NCT01361399, titled an active and placebo controlled study to test the efficacy and safety of an aspirin-lidocaine lozenge in the symptomatic treatment of sore throat associated with a common cold. It enrolled 1,088 participants in Russia and Ukraine.
The completed Phase 3 trial NCT01361399 was randomized, double blind, and placebo controlled, with an active comparator arm. It enrolled 1,088 adults with sore throat associated with a common cold, pharyngitis, or tonsillitis. Participants were 18 years or older, and healthy volunteers were excluded.