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Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold

Common Cold Clinical Trial

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

Clinical Trial Summary

Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05070650
Study type Interventional
Source Sandoz
Contact Sandoz
Phone +49 8024 908 0
Email sandoz.disclosure@sandoz.com
Status Not yet recruiting
Phase Phase 3
Start date September 20, 2024
Completion date April 30, 2025
View Details
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