NCT01537081

Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,810 (actual)
• Sponsor: Reckitt Benckiser LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Upper Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	Mucinex	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.
DRUG	Immediate-release Guaifenesin	Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
DRUG	Placebo	Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2012-02-22
• Last updated: 2013-11-14
• Results posted: 2013-09-12

Locations

43 sites across 1 country: United States