NCT05070650

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

Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Acetylcysteine	200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day
DRUG	Paracetamol	500 mg/10 mg granules for oral solution: one sachet three times per day
DRUG	Phenylephrine	500 mg/10 mg granules for oral solution

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2021-10-07
• Last updated: 2024-09-26