Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold
brief summary
Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients
detailed description
This study is a prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients.
Patients will undergo screening examinations at Visit 1.
Patients who meet all of the inclusion and none of the exclusion criteria will be randomized to double-blind treatment with one of the following:
* Group A: Acetylcysteine/Paracetamol/Phenylephrine: one sachet three times per day OR * Group B: Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day.
A control visit (Visit 2) is planned on Day 3 of treatment.
After the end of the double-blind treatment phase, the patients will undergo an end-of-treatment (EOT) examination at Visit 3 on Day 6.
official title
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial