At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d) in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days
In Brief
A Phase 3 clinical trial evaluating Mucinex, Immediate-release Guaifenesin, and 1 other intervention for Acute Upper Respiratory Tract Infection. Completed, enrolled 2,810 participants across 43 sites.
Detailed Summary
The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.
Study Details
Timeline
Interventions
Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet. Each tablet was 600 mg of guaifenesin and taken by mouth with a full glass of water.
Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water