Conditions: Acute Upper Respiratory Tract Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2810
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600 mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet. arm 2: The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days. arm 3: Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.

Interventions: intervention 1: Mucinex intervention 2: Immediate-release Guaifenesin intervention 3: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water. intervention 3: Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water

Protocol document: