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

Reckitt Benckiser

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Upper Respiratory Tract Infection

Treatments: Drug: Mucinex; Drug: Immediate-release Guaifenesin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537081

2011-MUC-04

Details and patient eligibility

About

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.

Enrollment: 2,810 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

Exclusion criteria

1. Chronic illnesses.
2. Febrile illness > 101 F within 7 days prior to Day 1,
3. Pregnant.
4. Known current malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,810 participants in 3 patient groups, including a placebo group

Mucinex 2400 mg/day

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Mucinex

Immediate-release Guaifenesin 800 mg/Day

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Immediate-release Guaifenesin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo