Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Reckitt Benckiser LLC
Treatments:
Chlorpheniramine, phenylpropanolamine drug combination Guaifenesin Phenylpropanolamine